Knee OA Evaluation of treatment with orthotics (wedged insole and knee brace) Preliminary data

2. Knee OAEvaluation of treatment with orthotics (wedged insole and knee brace)Preliminary data Kjell G Nilsson, MD, PhD, FRACS Jan Karlsson, CPO Department of Orthopaedics Umeå University hospital Umeå, Sweden

3. Osteoarthrosis (OA) • OA is a very common disease • More common than diabetes and heart diseases • Incidence increases with age • However, common even in younger patients • approx 5 % between 35 och 54 years have OA

4. 90 80 70 60 50 40 30 20 10 0 30 40 50 60 70 80 Prevalence of OA (%) Finger OA Knee OA Hip OA Age

5. OA • Cost for the society (Sweden 2002) • Direct costs (drugs and treatmenmt) • 2 billion SEK • Sick leave and loss of income and loss of production • 10 billion SEK

6. Symptoms of OA at the knee • Swelling • Tenderness • Pain at rest • Deformity • Often insidious onset • Stiffness • Decreased mobility and range of motion • Crepitations • Pain with activity

8. ? Treatment of OA Few Some All

9. Treatment of knee OA with orthotics • Wedged insole (keel) • Brace Suggested function: • Reduce the load on the concave side of the deformity during weight bearing (“dynamic unloading”) •  reduce pain

10. Wedged insole Suggested function Reduce the load (varus moment) lateral keel reduce pain

11. Wedged insole + brace Suggested function Reduce the load (varus moment) keel + valgusbrace (three point pinciple) reduce pain

12. Treatment of knee OA with orthotics • Several studies have shown biomechanical effects of wedged insoles and knee braces But • What about their clinical effects??

15. Questions • What are the effects (if any) (as measured by KOOS) of • 1. Wedged insole (keel) only • 2. Wedged insole (keel) + varus or valgus brace • Do all patients require brace? Or is insole sometimes enough? • Are there gender differences? • Are there age differences?

16. Knee Injury and Osteoarthritis Outcome Score (KOOS) • A knee specific instrument • Consists of 5 subscales • 1. Pain 9 questions • 2. Other symptoms 7 questions • (swelling, joint movement, mechanical symptoms) • 3. Function in daily living (ADL) 17 questions • 4. Function in sports and recreation 5 questions • 5. Knee related Quality of Life (QoL) 4 questions • Each answer alternative is scored 0 to 4 Roos, Lohmander et al, Health Qual Life Outcomes 2003:1:64 Roos, Roos, Lohmander et al, Scand J Med Sci Sports 1998:8:439 Roos, Roos, Lohmander et al, J Orthop Sports Phys Ther 1998:28:88

17. All scores for each subscale are summarized and thereafter normalized to a 0-100 scale 0 extreme knee symptoms 100 no knee symptoms A total score for all 5 subscales is NOT calculated KOOS

18. Change over time “Effect Size” After Before KOOS After treatment Before treatment (After – Before)/SD (Before)

19. Effect size, examples

20. Present Study • Initially, offer all patients a laterally or medially wedged insoleFollow up minimum 6 weeks • For those who are unsatisfied with insole, offer a knee brace in addition to insoleFollow up minimum 6 weeks • (Plan: Continued follow up of all patients > 5 years)

21. Patient logistics (1) • Referred from the Orthopaedic Department • Medial or lateral OA as confirmed by X ray • Clinical symptoms of OA • No inflammatory arthritis • For various reasons not ready for surgery • (Too young, too old, too infirm, not mentally ready for surgery, want to try conservative treatment before accepting operation, etc…)

22. Methods (1) • 1. After receiving the referral • Information letter and 1st KOOS questionnaire sent to the patient • KOOS form to be filled out before first visit • 2. First visit • 1st KOOS form collected (i.e. PRE treatment form) • Repeat information about the study • 10 degree laterally or medially wedged insole (keel) given to all patients • 2nd KOOS form given, to be sent back after ≥ 6 weeks of insole/keel treatment (i.e. keel/insole form) • Asked to indicate after 6 weeks if insole/keel treatment is sufficient or insufficient

23. Methods (2) • Second visit(for those patients who felt insole/keel treatment was insufficient) • All these patients received a varus or valgus brace to be used in addition to the wedged insole/keel • Given a 3rd KOOS form (insole/keel-brace form) to be filled in after ≥ 6 weeks of treatment with insole/keel + brace treatment

24. Insole/keel treatment 90 KOOS forms received after 6 weeks treatment with insole/keel 120 KOOS formscorrectly filled out 56 patients satisfiedwith insole/keel treatment 34 patients NOT satisfiedwith insole/keel treatment Addition ofbrace 34 KOOS forms received after 6 weeksof insole/keel treatment Patient logistics (2) 136 referrals received

25. N = 90, mean age 58 y 47 men (mean 56 y) 43 women (mean 60 y) (Bilat OA n=19) - (10 men, 9 women) Medial (38 men, 36 women) Lateral OA n=16 (18%) - (9 men, 7 women) Patients

26. Inlay sole:10° laterally or medially based keel

27. Braces used

28. Custom CarbonFibre 1 patient

29. DonJoy (11-0872) 1 patient

30. Camp (Breg 0700, Breg 25262) 8 patients

31. Custom, DonJoy, Camp • Difficult to adjust to the patients • Felt by the patient to be “bulky” • Relatively small pads for soft tissue pressure • Abandoned after 10 patients

32. Össur Unloader One 24 patients

33. Össur Unloader One • Large pads for soft tissue contact and pressure • Easy to adjust to the individual patient • Easy to apply and remove • Easily accepted by the patient • Therefore used in the majority of the patients (the last 24)

34. Preliminary data

35. Effect of a wedged insole

36. 100 Keel Pre 80 60 40 20 0.05 ns ns ns 0.003 0 Pain Symptoms ADL Sports QoL Insole/Keel (90 patients) Paired t test Mean values± 95% CI

37. 100 Keel Pre 80 60 40 20 ns ns ns ns ns 0 Pain Symptoms ADL Sports QoL Insole/Keel (women) Paired t test Mean values± 95% CI

38. 100 Keel Pre 80 60 40 20 0.01 ns ns ns 0. 002 0 Pain Symptoms ADL Sports QoL Insole/Keel (men) Paired t test Mean values± 95% CI

39. Some improvement in total material Effect size 0.10 (symptoms) to 0.31 (QoL) Smaller effect in women Effect size 0.05 (symptoms) to 0.27 (QoL) Larger effect in men Effect size 0.10 (symptoms) to 0.55 (QoL) Summary: Effects of Insole/Keel

40. Men Keel Men Pre 100 Women Pre Women Keel 80 60 40 20 Women keelvsmen keel 0.17 0.02 0.006 0.004 0.04 0.09 0.11 0.17 0.45 0.81 Women prevsmen pre 0 Pain Symptoms ADL Sports QoL Women vs men w and w/o insole/keel Un-paired t test

41. Effects of insole/keel and age

42. 100 Keel Pre 80 60 40 20 ns ns ns ns ns 0 Pain Symptoms ADL Sports QoL Insole/Keel (age < 60 years) Paired t test Mean values± 95% CI

43. 100 Keel Pre 80 60 40 20 0.04 ns 0.04 ns 0.001 0 Pain Symptoms ADL Sports QoL Insole/Keel (age > 60 years) Paired t test Mean values± 95% CI

44. Small effect in the young (< 60 years) Effect size 0.00 (symptoms) to 0.17 (sports/recr) Larger effect in the elderly (> 60 years) Effect size 0.19 (sports/recr) to 0.64 (QoL) Summary: Effects of Insole/Keel and Age

45. Results after 6 weeks of insole/keel • 56 patients were satisfied • 34 patients were dissatisfied • Question: • Was there a difference in KOOS between those groups?

46. 100 80 34 Dissatisfied with keel 56 Satisfied with keel 60 40 20 0.02 0.28 0.08 0.71 0.02 0 Pain Symptoms ADL Sports QoL Satisfied vs dissatisfied after 6w with insole/keel Un-paired t test

47. Effects of insole/keelandbrace

48. 100 80 Keel + orthosis Pre 60 40 20 0.9 0.02 0.048 0.04 0.01 0 Pain Symptoms ADL Sports QoL Keel + Brace (34 patients) Paired t test Mean values± 95% CI

49. 100 80 Keel + orthosis Pre 60 40 20 0.29 0.32 0.30 0.53 0.54 0 Pain Symptoms ADL Sports QoL Keel + Brace (34 patients) Effect Size:

50. Summary: Effects of Keel and Brace • Significant improvement of all 5 subscales of KOOS • Effect size 0.29 (pain) to 0.54 (QoL)