SURGICAL TECHNIQUEIntegra® TITAN™ Humeral Resurfacing Arthroplasty

Table of Contents

Introduction

Indications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2Contraindications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2Design Features . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2System Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2Anatomic Sizing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3Surgical Technique Visual Step-by-Step . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

Surgical Technique

Preoperative Planning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5Anesthesia & Patient Positioning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5Step 1: Access & Incision . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5Step 2: Approach . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5Step 3: Preparation of the Humeral Head – Centralizing the Pin . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8Step 4: Sizing the Humeral Head . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8Step 5: Shaping the Head . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9Step 6: Center Drill Placement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10Step 7: Trial . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10Step 8: Drilling & Broaching of the Humeral Head . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11Step 9: Insertion of Component . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12Step 10: Closure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12Step 11: Postoperative Care . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13

Instrumentation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14Ordering Information. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Back Cover

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Design Features

System Overview

Indications

Contraindications

*ESSENTIAL PRODUCT USE INFORMATION: For additional important information pertaining to the use of this product, please see product package insert. This information was current at the time of printing, but may have been revised after that date.

Improper selection, placement, positioning, alignment and fixation of the implant may result in unusual stress conditions which may lead to subsequent reduction in the service life of the device. See package insert for full prescribing information.

The TITAN Humeral Resurfacing Arthroplasty System is intended for resurfacing of the humeral head due to non-inflammatory or inflammatory arthritis, mild or moderate humeral head deformity and / or limited motion, post-traumatic arthritis, and patients with an intact or reparable rotator cuff.

Absolute contraindications include: infection, sepsis, and osteomyelitis. Relative contraindications include: osteoporosis, metabolic disorders which may impair bone formation, osteomalacia, rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram, revision procedures where other devices or treatments have failed with associated loss of bone stock.

See package insert for full prescribing information.*

• Eight anatomic head geometries for minimal bone removal and proper fit • Highly polished Co-Cr articulating surface with Ti plasma spray undercoating for bone/osteo/osseosintegration and

secondary fixation• Large four-finned, fluted stem for optimal stability and initial fixation• Precise color-coded instrumentation designed for accuracy, reproducibility, and ease of implantation

The TITAN Humeral Resurfacing Arthroplasty system is an anatomic, cementless, monobody device designed for resurfacing of the humeral head. The system incorporates eight anatomical head geometries with appropriately sized stems to fit varying patient anatomy and pathology. Resurfacing addresses glenohumeral joint disease by replacing the damaged humeral head bearing surface and restoring nearly normal anatomy with minimal bone resection. The tapered stem has four large fluted fins that provide for rotational as well as axial stability of the seated implant. Precise instrumentation facilitates the surgical technique.

Surgical TechniqueAs the manufacturer of this device, Integra LifeSciences Corporation does not practice medicine and does not recommend this or any other surgical technique for use on a specific patient. The surgeon who performs any procedure is responsible for determining and using the appropriate technique in each patient.

Caution: Federal law restricts this device to sale by or on the order of a physician or practitioner.

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Anatomic SizingThe sizing of the TITAN Humeral Resurfacing implant is based upon scientific data and observations in the variability of humeral head size.1,2,3,4 Two studies, in particular, examined the anthropometric measurements of cadaveric human humeri and determined that normal shoulders exhibit a range of humeral head widths and heights. In addition, humeral head height correlates with humeral head width.1,3 Using the formula of H/R (H = height, R = spherical radius), data from these two studies are plotted on the chart below, which represents the humeral head anatomic dimensional range.

Based on these findings, and using the H/R formula, the sizing of the TITAN Humeral Resurfacing system was determined by identifying a mix of radius and height sizes that addresses the majority in the humeral head anatomic dimensional range. The design and sizing of the TITAN Humeral Resurfacing system make it an ideal option in reconstructing the variability in anatomic radius of curvature and thickness of the humeral head in the glenohumeral joint.

Catalog Number Head Size (mm) Stem

HRA-900-40/16 40 x 16 HRA-900-44/15 44 x 15 1 HRA-900-44/18 44 x 18 HRA-900-48/17 48 x 17 2 HRA-900-48/20 48 x 20 HRA-900-52/18 52 x 18 HRA-900-52/21 52 x 21 3 HRA-900-56/21 56 x 21

*In each cell below are H/R values. Numbers highlighted in light green represent the combined data of Iannotti and HertelNumbers highlighted in dark green represent TITAN implant sizes.

1 Iannotti JP, Gabriel JP, Schneck SL, et al: The normal glenohumeral relationships. An anatomical study of one hundred and forty shoulders. J Bone Joint Surg (Am), 1992; 74:491-500.2 Williams GR and Iannotti JP: Anatomy and biomechanics of the glenohumeral joint related to shoulder arthroplasty, Seminars in Arthroplasty, Vol 11, No 1 (January): pp 2-15.3 Hertel R, Knothe U and Ballmer F: Geometry of the proximal humerus and implications for prosthetic design. J Shoulder Elbow Surg. Vol. 11, No 4, 2002; 331-338.4 Boileau P and Walch G: The three-dimensional geometry of the proximal humerus. J Bone Joint Surg (Br) Vol 79-B, No 5, Sept 1997:857-865.

*Humeral Head Anatomic Dimensional Range

W \ H 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25

32 0.64 0.72 0.80 0.87 0.94 1.00 1.06 1.12 1.17 1.22 1.27 1.31 1.35 1.38 1.42

33 0.62 0.69 0.77 0.84 0.90 0.97 1.03 1.09 1.14 1.19 1.24 1.28 1.32 1.36 1.39

34 0.59 0.67 0.74 0.81 0.88 0.94 1.00 1.06 1.11 1.16 1.21 1.25 1.29 1.33 1.37

35 0.57 0.64 0.71 0.78 0.85 0.91 0.97 1.03 1.08 1.13 1.18 1.22 1.27 1.31 1.34

36 0.54 0.62 0.69 0.75 0.82 0.88 0.94 1.00 1.05 1.10 1.15 1.20 1.24 1.28 1.32

37 0.52 0.59 0.66 0.73 0.79 0.86 0.92 0.97 1.03 1.08 1.13 1.17 1.21 1.25 1.29

38 0.50 0.57 0.64 0.70 0.77 0.83 0.89 0.95 1.00 1.05 1.10 1.15 1.19 1.23 1.27

39 0.48 0.55 0.62 0.68 0.74 0.80 0.86 0.92 0.97 1.03 1.07 1.12 1.16 1.20 1.24

40 0.46 0.53 0.59 0.66 0.72 0.78 0.84 0.90 0.95 1.00 1.05 1.10 1.14 1.18 1.22

41 0.45 0.51 0.57 0.64 0.70 0.76 0.81 0.87 0.92 0.98 1.02 1.07 1.11 1.16 1.20

42 0.43 0.49 0.55 0.62 0.68 0.73 0.79 0.85 0.90 0.95 1.00 1.05 1.09 1.13 1.17

43 0.41 0.48 0.54 0.60 0.65 0.71 0.77 0.82 0.88 0.93 0.98 1.02 1.07 1.11 1.15

44 0.40 0.46 0.52 0.58 0.63 0.69 0.75 0.80 0.85 0.90 0.95 1.00 1.04 1.09 1.13

45 0.39 0.44 0.50 0.56 0.62 0.67 0.73 0.78 0.83 0.88 0.93 0.98 1.02 1.06 1.10

46 0.37 0.43 0.48 0.54 0.60 0.65 0.71 0.76 0.81 0.86 0.91 0.96 1.00 1.04 1.08

47 0.36 0.41 0.47 0.52 0.58 0.63 0.69 0.74 0.79 0.84 0.89 0.93 0.98 1.02 1.06

48 0.35 0.40 0.45 0.51 0.56 0.62 0.67 0.72 0.77 0.82 0.87 0.91 0.96 1.00 1.04

49 0.34 0.39 0.44 0.49 0.55 0.60 0.65 0.70 0.75 0.80 0.85 0.89 0.94 0.98 1.02

50 0.32 0.37 0.43 0.48 0.53 0.58 0.63 0.68 0.73 0.78 0.83 0.87 0.92 0.96 1.00

51 0.31 0.36 0.41 0.46 0.51 0.56 0.62 0.67 0.71 0.76 0.81 0.85 0.90 0.94 0.98

52 0.30 0.35 0.40 0.45 0.50 0.55 0.60 0.65 0.70 0.74 0.79 0.83 0.88 0.92 0.96

53 0.29 0.34 0.39 0.44 0.49 0.53 0.58 0.63 0.68 0.73 0.77 0.82 0.86 0.90 0.94

54 0.28 0.33 0.38 0.42 0.47 0.52 0.57 0.62 0.66 0.71 0.75 0.80 0.84 0.88 0.92

55 0.28 0.32 0.37 0.41 0.46 0.51 0.55 0.60 0.65 0.69 0.74 0.78 0.82 0.86 0.90

56 0.27 0.31 0.35 0.40 0.45 0.49 0.54 0.58 0.63 0.68 0.72 0.76 0.81 0.85 0.89

57 0.26 0.30 0.34 0.39 0.43 0.48 0.52 0.57 0.62 0.66 0.70 0.75 0.79 0.83 0.87

58 0.25 0.29 0.33 0.38 0.42 0.47 0.51 0.56 0.60 0.64 0.69 0.73 0.77 0.81 0.85

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Surgical Technique – Visual Step By Step

Incision Approach

Centralizer / Sizer Shaper

Center Drill Trial

ImplantationBroach

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Step 1 • Access & Incision

Preoperative Planning

Anesthesia & Patient Positioning

Step 2 • Approach

Depending on surgeon preference, either the deltopectoral or the superior approach (commonly known as McKenzie’s) can be used. The advantages of the deltopectoral approach include preservation of the deltoid origin and insertion, utilization of an extensile exposure, and facilitation of subscapularis lengthening. The superior approach may be preferred since it offers retention of the subscapularis. Since the deltopectoral approach is the most typical approach for this procedure, the surgical technique will highlight this approach only.

A deltopectoral approach is used to provide exposure to the anterior aspect of the glenohumeral joint, the upper humeral shaft, and the humeral head. An appropriate incision is made from the clavicle over the coracoid towards the deltoid insertion (length varies depending on the size and stiffness of the shoulder) If necessary, extend the incision distally to facilitate the exposure. The clavipectoral fascia is incised.

Template x-rays to select the appropriate size implant (be wary of radiographic mismatch). Humeral head size is verified intraoperatively by measuring the head after osteophyte removal, if present.

Proximal humeral resurfacing using the TITAN implant can be performed using general anesthesia, regional anesthesia (i.e., interscalene block), or a combination.

Place the patient in beach chair position (see right). This position would have the patient supine with the hips flexed approximately 30°, knees bent approximately 30°, and back elevated approximately 30°. Specialized headrests, arm mounts, or operating tables with breakaway side panels can facilitate further access to the top and back of the shoulder.

Locate the cephalic vein, 1-1. The cephalic vein is mobilized laterally with the deltoid. Peripheral vascular branches are coagulated. The arm is abducted 40-60° with 20° external rotation. The subacromial space is swept clear with blunt dissection and a Chandler, cobra-type retractor is placed under the deltoid insertion between the rotator cuff and deltoid . A spiked Hohmann retractor is placed superior to the acromion between the acromion and inserting deltoid fibers. The sub-deltoid retractors included in the tray are placed with the arm in slight abduction and external rotation to facilitate visualization of the acromion and rotator cuff. The coracoacromial ligament is always preserved. Improved exposure can be obtained by releasing the superior 2cm of the insertion of the pectoralis major adjacent to the humerus.

1 - 1

2 - 1 2 - 1

1- 1

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2 -2 2 -2

2 -3 Next release the insertion of the subscapularis by sharp dissection 1 cm medial to the lesser tuberosity, through both tendon and capsule, or by an osteotomy of the lesser tuberosity to gain access to the glenohumeral joint. Place traction sutures in the subscapularis tendon to control and mobilize it from the anterior glenoid neck. The subscapularis traction sutures will be utilized as a “shoe horn” to control the humeral head dislocation and relocation.

Blunt dissection, inferior to the subscapularis, is carried out for direct visualization or palpation of the axillary nerve. The location of the axillary nerve should be known throughout the procedure. The biceps groove is palpated just medial to the pectoralis insertion.

NoteIn selected cases, the long head of the biceps tendon is transected at the transverse humeral ligament and later tenodesed or left tenotomized.

NoteA lesser tuberosity osteotomy may also be performed to take down the subscapularis if it is attenuated. The ‘subscapularis tendon-capsule complex’ is dissected and elevated as one unit from the humerus at the medial aspect of the bicipital groove. If this complex is contracted, a 360° release of the subscapularis must be performed to mobilize the tendon to gain eventual external rotation. This is performed with a careful anterior and inferior capsular release.

2 -3

The joint capsule is released anteriorly and inferiorly as needed, primarily from the humerus. Preservation of some of the posterior capsule is maintained to facilitate centralization and prevent posterior subluxation. Take care to protect the axillary nerve as it passes inferior to the subscapularis and capsule. A blunt Cobra retractor is placed between the axillary nerve and the capsule-tendon complex.

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2 -4

2 -5

2 -4

2 -5

Release of the anterior, inferior, and posterior gleno-humeral ligaments is vital in properly and concentrically centralizing the humeral head as noted above. At this point, the humeral head should freely rotate into maximum external rotation, slight abduction, and significant extension, allowing the head to dislocate anteriorly for preparation of the humeral head.

Full exposure of the humeral head, neck, and glenoid can now be achieved. The angled Hohmann retractors included in the set will be of great help in delivering the humeral head to the proper position while carefully protecting the adjacent soft tissue.

NoteThe humeral head must be anteriorly translated without soft tissue interposition.

Proper anterior and inferior capsular releases are needed for ease of dislocation and proper humeral head preparation, as well as re-establishing concentricity of the gleno-humeral joint. Releasing the inferior capsule off the humerus is an essential pearl in gaining exposure, at least past the 6 o’clock position. Bone preparation is initiated by debridement of sufficient amount of anterior inferior osteophytes to properly identify the anatomic neck.

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Step 3 • Preparation of the Humeral Head – Centralizing the Pin

Step 4 • Sizing the Humeral Head

The Centralizer/Sizer instrument has two functions: (1) to find the center of the anatomic humeral head, and (2) to determine the implant size that best fits the patient’s anatomy. Choose the Centralizer/Sizer that easily fits over the unshaped humeral head. The proper Centralizer/Sizer is determined by choosing the one that fits on the deformed head with or without removal of osteophytes and with little if any protrusion.

With the Steinmann pin in place, use the Centralizer/Sizer to determine the implant size. The Centralizer/Sizer’s outer dimensions are the same as the implant’s outer dimension. The inside dimensions of the Centralizer/Sizer are the same as the inside dimension of the implant and the inside dimensions of the shaper. Therefore, the inside of the Centralizer/Sizer will indicate the amount of bone resection performed by the shaper.

Select the proper diameter first. Choose a Centralizer/Sizer that fits slightly protruded on the head. The correct size will allow the shaper to create a small rim of bone on which the implant will fit with minimal protruding edges. It is important to ensure that there is minimal implant overhang especially at the superior and anterior surface. If choosing between diameters, pick the smaller of the two.

3- 1

4- 1

3- 1

4- 1

NoteRemove osteophytes as needed to visualize neck and shaft.

NoteTake care to ensure placement of the Centralizer/Sizer in center of both anterior-posterior and varus-valgus (err slightly in valgus). The sizer should almost abut the supraspinatus superiorly and leave approximately 5 mm posteriorly to accommodate the bare area near the infraspinatus tendon insertion.

Determine the center of the head, taking into account osteophytes and/or bone missing or removed. The anatomical neck of the humerus circumferentially must be visualized to identify the exact neck-shaft angle. Place the Centralizer/Sizer over the central axis of the articular surface in alignment with the proper neck-shaft angle (approximately 135°).

Use a wire driver to place the Steinmann pin through the cannulated Centralizer/Sizer and out the lateral cortex. The Centralizer/Sizer is then removed to verify the Steinman pin is centered both anterior-posterior and superior-inferior as well as 135° of inclination. Reposition Steinman pin if necessary, using the Centralizer/Sizer.

SZR-900-XX-XX* Sizer / Centralizer* See variable sizes on back page

Good fit – shaping will create a rim of bone for implant to seat.

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SHP-900-XX-XX* Shaper

Step 5 • Shaping the Head

Once the desired diameter is selected, the closest head height is chosen. If the taller height is initially chosen, shaping should proceed until either bone removal is seen at the center of shaper or the peripheral articular surface near the anatomic neck is reached. If the peripheral articular surface near the anatomic neck is reached before bone is removed from the center, shaping should be completed using the shorter height. If the shorter height is initially chosen, then shaping should proceed until bone removal is seen at the center of the shaper. If too much peripheral articular surface near the anatomic neck remains, then shaping should be completed using the taller height.

The humeral head Shaper corresponding to the previously selected Centralizer/Sizer is placed over the Steinmann pin. The humeral head is debrided and shaped to the proper roundness.

5- 1 5- 1

NoteSize of the rim may vary or may not be present.

NoteDuring Steps 5-8, maintain alignment with Steinmann pin and avoid dropping the arm or elbow during humeral head shaping, drilling, or broaching.

NoteAdequate retraction of soft tissues throughout the shaping operation is important. The Shaper contains a stop that will control the amount of bone resected.

NoteGaining rotational speed on the Shaper prior to contact with the humeral head will enhance the quality of the cut without generating excessive torque. Try to see bone shavings through the windows of the shaper.

Remove Shaper and use the Centralizer/Sizer to visually confirm that the amount of bone resected is adequate.

The Centralizer/Sizer is the same size as the Shaper and implant. Re-shaping can be performed if more shaping or a smaller diameter or shorter height implant is required. All remaining protruding osteophytes are removed, with an osteotome or rongeur as needed.

* See variable sizes on back page

10

Step 6 • Center Drill Placement

Step 7 • Trial

The pilot hole for the implant’s stem is made by placing the size 1 cannulated Center Drill over the Steinmann pin.

Select the cannulated Trial corresponding to the shaper used and pass it over the Steinmann pin. Visually evaluate the fit of the Trial to ensure complete seating. If the Trial does not seat completely, look for impeding bone ridges or osteophytes and remove them with a rongeur/osteotome. If the Trial significantly protrudes over the humeral head, try a smaller diameter or shorter head height, or use the Shaper to re-shape in order to gain more adequate fit.

Trial reduction can be accomplished by removing the pin. Stability and range of motion can be tested at this time (e.g. the hand can easily go to the opposite axilla and at least 30° of external rotation can be achieved before anterior subluxation/dislocation). There should be smooth 25-50% posterior and inferior translation of the humerus with the arm in neutral rotation. The determination of glenohumeral joint stability and assessment of the proper re-attachment point of the subscapularis-capsule complex should be verified. Confirm that there are no excess bone edges protruding, especially at the superior surface.

6- 1

7- 1

6- 1

7- 1

NoteIf the Steinmann pin has backed out, replace the Centralizer/Sizer and redrill the Steinmann pin.

NoteIf re-sizing is required, place appropriately sized Adapter Plug in pilot hole to stabilize Shaper. Reshape as needed.

Using a cannulated power drill, drill until the Center Drill collar contacts the humeral head on all sides. The Center Drill is removed leaving the Steinmann pin in place. (All morselized bone generated by making this drill hole should be saved and used for possible grafting).

Excess bone edges must be smoothed along the prosthesis edge if present. It is most important to remove excess bone along the superior margin of the prosthesis to provide the least amount of rotator cuff or biceps tendon irritation.

CTD-900-XX* Center Drill

TRL-900-XX-XX*Trial

ADP-900-XX*Adaptor Plug

* See variable sizes on back page

* See variable sizes on back page

* See variable sizes on back page

* See variable sizes on back page

11

Step 8 • Drilling & Broaching of the Humeral HeadFinal preparation of the humeral head can now be completed. Note the final implant size. The stems of the implants increase as the diameter increases. The table at right indicates the center drilling and broaching sequence for each implant size.

Replace the Steinmann Pin with the Sizer/Centralizer if it had been previously removed. Always carry out all necessary drilling before broaching.

Once drilling is complete, the broaching sequence starts by using the Starter Broach to initiate the cruciform configuration. The Starter Broach is placed over the Steinmann pin and advanced into the pilot hole with a mallet. Carefully maintain proper valgus-varus and version to ensure complete seating of the Starter Broach against the humeral head. Remove the Starter Broach and continue to increase broach sizes as indicated, stopping at the corresponding stem size (see chart at right).

Example of drilling and broaching sequence: If a size 52/18 is chosen, the sequential steps are as follows:

• Center Drill, Size 1• Center Drill, Size 2• Center Drill, Size 3• STARTER BROACH• Broach 1• Broach 2• Broach 3

8- 1 8- 1

NoteDrilling and broaching sequence must be followed in order for the prosthesis to seat properly.

IMPLANT STM DRL 1 DRL 2 DRL 3 ST BRH BRH 1 BRH 2 BRH 3

40/16 1 • • •44/15 1 • • •44/18 1 • • •48/17 2 • • • • •48/20 2 • • • • •52/18 3 • • • • • • •52/21 3 • • • • • • •56/21 3 • • • • • • •NOTE: Size 1, 2 and 3 Adapter Plugs are provided if reshaping is necessary after use of Size 1, 2 or 3 Center Drills respectively.

BRH-900-XX* Broach

BRH-900-00 Starter Broach

* See variable sizes on back page

12

Step 9 • Insertion of Component

Step 10 • Closure

Once the final broaching sequence is complete the humeral head is fully prepared to receive the implant. Irregularities or defects in the humeral head may be grafted using bone that has previously been removed, or a bone substitute.

Place the selected prosthesis into the prepared humeral head and initially seat with finger pressure. The humeral prosthesis is then impacted until it is flush against the bone. Before final reduction, irrigate the joint to remove loose tissue and palpate the glenoid.

While applying tension to the subscapularis stay sutures, the humeral head is now reduced. Assess the position of reattachment of the subscapularis. Proper balance of soft tissue is the most important consideration. The subscapularis is repaired using No. 1 or No. 2 non-absorbable sutures without plication and excessive lateralization. Suture anchors may also be used, but are rarely necessary if the appropriate remnant of the subscapularis is left and releases are performed.

The rotator interval is closed just laterally with one buried suture. If there is any rotator cuff deficiency or defect, then rotator cuff repair is made in the normal manner at this stage. Preparation and mobilization of the rotator cuff may be accomplished at any stage of this procedure. It is suggested that the most advantageous time is at the trial reduction. Every attempt is made to close the rotator cuff completely. The delto-pectoral interval is closed over a drain. Subcutaneous tissue is opposed with absorbable sutures and appropriate skin closure is undertaken.

9- 1 9- 1

NoteThe device is designed for press fit fixation. Use of cement may not allow implant to properly seat.

* See variable sizes on back page

13

Step 11 • Postoperative CareThe patient is placed in a comfortable immobilizer with arm at their side and regional block analgesia as preferred. Pendulum exercises are not encouraged in order to prevent stretch of the anterior repair. However, supine passive range of motion within 24-72 hours of surgery is of the utmost importance. The limits to the extent of passive range of motion performed should not exceed the safe zone of rotation observed at surgery after subscapularis closure.

Supervised physical therapy program is recommended after 24-48 hours. Supervised active assisted and passive range of motion mobilization is suggested for the first 72 hours. Active assisted and passive assistance is recommended for 6 weeks after which terminal stretching and active range of motion is initiated. Home pulley system is initiated at 72 hours.

The sling immobilizer may be abandoned at approximately 6 weeks to protect the subscapularis repair. Most patients are able to perform all their exercises at home in a physician supervised therapy program. Supervision of all post-operative therapy is recommended. Therapy should be individualized and based on the status of the repaired tissues and muscle strength. Most importantly, protection of the subscapularis repair and/or rotator cuff repair will dictate the amount of stretching or resistance as well as the duration of immobilization. Progressive resistance for the rotator cuff including the subscapularis is initiated at 10-12 weeks depending on the quality of rotator cuff tissue and of the repair. Guarded loading of the shoulder should be observed for the first 4-6 months post-op. Complete recovery from surgery occurs at 9-12 months.

14

1. Retractors

2. Steinmann Pins

3. Sizer / Centralizers

4. Shapers

5. Center Drills

6. Trials

7. Adapter Plugs

8. Starter Broach

9. Broaches

10. Impactor

Instrumentation

1

10

8 95

6

7

2

3

4

Integra®

TITAN™ Humeral Resurfacing Arthroplasty

A B C D Size Diameter Head Height Overall Length Stem Width

40-16 40.0 16.0 29.7 16.844-15 44.0 15.0 29.7 16.944-18 44.0 18.0 29.7 16.648-17 48.0 17.0 32.3 19.348-20 48.0 20.0 32.3 19.152-18 52.0 18.0 34.8 21.752-21 52.0 21.0 34.8 21.556-21 56.0 21.0 34.8 21.5

Catalog Number

Catalog Number

Implants

Instruments

HRA-900-40/16 TITAN Implant, Size 40/16 HRA-900-44/15 TITAN Implant, Size 44/15HRA-900-44/18 TITAN Implant, Size 44/18HRA-900-48/17 TITAN Implant, Size 48/17HRA-900-48/20 TITAN Implant, Size 48/20HRA-900-52/18 TITAN Implant, Size 52/18HRA-900-52/21 TITAN Implant, Size 52/21HRA-900-56/21 TITAN Implant, Size 56/21

SZR-900-40/16 Sizer / Centralizer, Size 40/16SZR-900-44/15 Sizer / Centralizer, Size 44/15SZR-900-44/18 Sizer / Centralizer, Size 44/18SZR-900-48/17 Sizer / Centralizer, Size 48/17SZR-900-48/20 Sizer / Centralizer, Size 48/20SZR-900-52/18 Sizer / Centralizer, Size 52/18SZR-900-52/21 Sizer / Centralizer, Size 52/21SZR-900-56/21 Sizer / Centralizer, Size 56/21SHP-900-40/16 Shaper, Size 40/16SHP-900-44/15 Shaper, Size 44/15SHP-900-44/18 Shaper, Size 44/18SHP-900-48/17 Shaper, Size 48/17SHP-900-48/20 Shaper, Size 48/20SHP-900-52/18 Shaper, Size 52/18SHP-900-52/21 Shaper, Size 52/21SHP-900-56/21 Shaper, Size 56/21CTD-900-01 Center Drill, Size 1CTD-900-02 Center Drill, Size 2CTD-900-03 Center Drill, Size 3TRL-900-40/16 Trial, Size 40/16TRL-900-44/15 Trial, Size 44/15TRL-900-44/18 Trial, Size 44/18TRL-900-48/17 Trial, Size 48/17TRL-900-48/20 Trial, Size 48/20TRL-900-52/18 Trial, Size 52/18TRL-900-52/21 Trial, Size 52/21TRL-900-56/21 Trial, Size 56/21ADP-900-01 Adapter Plug, Size 1ADP-900-02 Adapter Plug, Size 2ADP-900-03 Adapter Plug, Size 3BRH-900-00 Starter BroachBRH-900-01 Broach, Size 1BRH-900-02 Broach, Size 2BRH-900-03 Broach, Size 3IMP-900-01 ImpactorRET-900-01 Retractors605 280 230 Unthreaded Steinmann Pin605 283 230 Threaded Steinmann Pin

Description

Description

Implant Dimensions (mm)

USA 800-654-2873 n 888-980-7742 faxInternational +1 609-936-5400 n +1 609-750-4259 faxintegralife.com/contact

United States, Canada, Asia, Pacific, Latin AmericaAscension Orthopedics, Inc.11101 Metric BlvdAustin, TX 78758 n USA

Manufacturer:

Availability of these products might vary from a given country or region to another, as a result of specific local regulatory approval or clearance requirements for sale in such country or region. n Non contractual document. The manufacturer reserves the right, without prior notice, to modify the products in order to improve their quality.n Warning: Applicable laws restrict these products to sale by or on the order of a physician.n Consult product labels and inserts for any indication, contraindications, hazards, warnings, precautions, and instructions for use.

For more information or to place an order, please contact:

Integra and the Integra logo are registered trademarks of Integra LifeSciences Corporation or its subsidiaries in the United States and/or other countries. TITAN is a trademark of Integra LifeSciences Corporation or its subsidiaries. ©2017 Integra LifeSciences Corporation. All rights reserved. Printed in USA. 0M 0723787-2-EN LC-04-907-001 Rev. D