AA023 - Audit of Clinical Outcomes from Unloader

braces provided in an ICATS MSK service in line with

NICE guidelines 177 (1.4.8) on Osteoarthritis

Mr David Stanley

Extended Scope Physiotherapist

Study Background • Braces classically been

provided in Secondary care within Orthotic service.

• Integrated MSK service should be able to provide/offer all non surgical treatments.

• Improve QoL, avoid delay and prevent or delay surgical intervention

Evidence?

“1.4.8 People with osteoarthritis who have biomechanical joint pain or instability should be considered for assessment for bracing/joint

supports/insoles as an adjunct to their core treatments. [2008] “

Evidence?

• 20/24 studies showed significant reduction in Knee adduction moment.

• 7 Showed decrease in pain (secondary outcome measure)

• 63 patients off surgical wait list, mean wear time 26/12

• 25 (40%) did not require surgery

• 38 (60%) had surgery, 50% TKR 37% UKR, 13% HTO

• Wearing for 6 months halved chance of needing surgery

• Patients who wore the brace for 2 years or more did not require surgery at 8 years follow-up.

• QALY gain of 0.44

• Particularly useful in younger age group (<50) as delaying surgery could reduce the demand for highly complex and expensive revision knee surgery

Criteria

• Unicompartmental (medial or lateral) disease

• Not significant PFJ disease or pain generation

• Significant pain – mechanical based

• Good level of activity

• ?Not yet suitable for joint replacement

• Pre-cursor to consideration for Osteotomy/Uni knee

• Not morbidly Obese

• Motivated and compliant

• Should be able to fully extend and comfortable on “unloading”

Subjects

• 70 fitted

• 5 Lateral, 65 Medial

• 60 Unloader one, 10 Unloader Fit

• 53 sets of data @ 6/52 (25 % drop out rate)

• 43 sets of data at 3/12 (39% drop out rate)

• 31 sets of data at 6/12 (56% drop out rate)

• Outcome Data collected – VAS, Oxford Knee Score, PGIC, KOOS

Subjects • Lost to follow up reasons

– Outcomes not received in post, no FU booked

– End of trial – so no further data collected

– Too uncomfortable for work

– Referred for surgery

– Too limiting for clothing options

– Blistering and rubbing

–Exacerbated PFJ Sx

– DNA

• Evidence supports poor compliance/adherence and adverse effects common (25%- 40% if poorly fitted)

Outcome - Pain

0.0

1.0

2.0

3.0

4.0

5.0

6.0

7.0

Initial 6 week 3 month 6 month

6.0

3.4 3.5 3.5

Visual Analogue Scale

Mean

Outcome - OKS

-2.0

3.0

8.0

13.0

18.0

23.0

28.0

33.0

38.0

43.0

48.0

Initial 6 week 3 month 6 month

24.8

30.0 30.3 30.8

Oxford Knee Score

Mean

Outcome - PGIC

1.0

2.0

3.0

4.0

5.0

6.0

7.0

6 week 3 month 6 month

4.4

4.1

4.8

Patient Global Impression of Change

Mean

Outcome - KOOS

0

10

20

30

40

50

60

70

80

90

100

KOOS Pain KOOS Symptom KOOS ADL KOOS Sport/Rec KOOS QOL

Initial Mean

Mean at 6/52

Mean at 3/12

Mean at 6/12

Outcome - evaluation • Results all very similar to preliminary trail of 17 patients

Audit plan

o Publication and inform local commissioning decisions??

o In depth analysis of drop out rate and surgical conversion to establish local cost effectiveness.