2. Knee OA Evaluation 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. Implant Research Unit Osteoarthrosis (OA) u OA is a very common disease u More common than diabetes and heart diseases u Incidence increases with age u However, common even in younger patients approx 5 % between 35 och 54 years have OA

4. 304050607080 0 10 20 30 40 50 60 70 80 90 Age Hip OA Knee OA Finger OA Prevalence of OA (%)

5. Implant Research Unit OA u 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  Often insidious onset  Stiffness  Decreased mobility and range of motion  Crepitations  Pain with activity  Swelling  Tenderness  Pain at rest  Deformity

7. Implant Research Unit

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

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. KOOS 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

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

19. Effect size, examples

20. Present Study 1.Initially, offer all patients a laterally or medially wedged insole Follow up minimum 6 weeks 2.For those who are unsatisfied with insole, offer a knee brace in addition to insole Follow up minimum 6 weeks 3.(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. Patient logistics (2) 136 referrals received 120 KOOS forms correctly filled out 90 KOOS forms received after 6 weeks treatment with insole/keel Insole/keel treatment 56 patients satisfied with insole/keel treatment 34 patients NOT satisfied with insole/keel treatment Addition of brace 34 KOOS forms received after 6 weeks of insole/keel treatment

25. Patients 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)

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. PainSymptomsADLSportsQoL 100 80 60 40 20 0 Pre Keel 0.05ns 0.003 Insole/Keel (90 patients) Paired t test Mean values ± 95% CI

37. PainSymptomsADLSportsQoL 100 80 60 40 20 0 Pre Keel 0.180.100.200.180.31 Insole/Keel (90 patients) Effect Size:

38. PainSymptomsADLSportsQoL 100 80 60 40 20 0 Pre Keel ns Insole/Keel (women) Paired t test Mean values ± 95% CI

39. PainSymptomsADLSportsQoL 100 80 60 40 20 0 Pre Keel 0.060.050.170.190.27 Insole/Keel (women) Effect Size:

40. PainSymptomsADLSportsQoL 100 80 60 40 20 0 Pre Keel 0.01ns 0. 002 Insole/Keel (men) Paired t test Mean values ± 95% CI

41. PainSymptomsADLSportsQoL 100 80 60 40 20 0 Pre Keel 0.280.100.190.180. 55 Insole/Keel (men) Effect Size:

42. Summary: Effects of Insole/Keel 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)

43. PainSymptomsADLSportsQoL 100 80 60 40 20 0 Men Pre Men Keel Women Pre Women Keel Women vs men w and w/o insole/keel 0.020.0060.040.170.45 Women keel vs men keel 0.170.0040.090.110.81 Women pre vs men pre Un-paired t test

44. Effects of insole/keel and age

45. PainSymptomsADLSportsQoL 100 80 60 40 20 0 Pre Keel ns Insole/Keel (age < 60 years) Paired t test Mean values ± 95% CI

46. PainSymptomsADLSportsQoL 100 80 60 40 20 0 Pre Keel 0.050.000.140.170.15 Insole/Keel (age < 60 years) Effect Size:

47. PainSymptomsADLSportsQoL 100 80 60 40 20 0 Pre Keel 0.04ns0.04ns0.001 Insole/Keel (age > 60 years) Paired t test Mean values ± 95% CI

48. PainSymptomsADLSportsQoL 100 80 60 40 20 0 Pre Keel 0.470.250.330.190.64 Insole/Keel (age > 60 years) Effect Size:

49. Summary: Effects of Insole/Keel and Age 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)

50. 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?

51. PainSymptomsADLSportsQoL 100 80 60 40 20 0 Satisfied vs dissatisfied after 6w with insole/keel 56 Satisfied with keel 34 Dissatisfied with keel 0.020.280.080.710.02 Un-paired t test

52. Effects of insole/keel and brace

53. PainSymptomsADLSportsQoL 100 80 60 40 20 0 Pre Keel + orthosis 0.90.020.0480.040.01 Keel + Brace (34 patients) Paired t test Mean values ± 95% CI

54. PainSymptomsADLSportsQoL 100 80 60 40 20 0 Pre Keel + orthosis 0.290.320.300.530.54 Keel + Brace (34 patients) Effect Size:

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

56. Effects of keel and brace and age

57. PainSymptomsADLSportsQoL 100 80 60 40 20 0 Pre Keel + orthosis 0.040.01 0.002 Keel + Brace (< 60 years) Paired t test Mean values ± 95% CI

58. PainSymptomsADLSportsQoL 100 80 60 40 20 0 Pre Keel + orthosis 0.500.450.580.870.83 Keel + Brace (< 60 years) Effect Size:

59. PainSymptomsADLSportsQoL 100 80 60 40 20 0 ns Pre Keel + orthosis Keel + Brace (> 60 years) Paired t test Mean values ± 95% CI

60. PainSymptomsADLSportsQoL 100 80 60 40 20 0 -0.100.12-0.13-0.270.00 Pre Keel + orthosis Effect Size Keel + Brace (> 60 years) Effect Size:

61. Summary: Effects of Keel and Brace and Age Highly significant improvement in all 5 subscales in younger patients (< 60 y) –Effect size 0.45 (symptoms) to 0.87 (sports/recr) No significant effect in older patients (>60 y) –Effect size -0.27 (sports/recr) to 0.12 (symptoms) Keel+Brace old

62. Effect size, examples Keel+Brace old Effect size summary

63. Discussion (1) This study shows that orthotics indeed are effective in treating OA There was improvement in every domain/subscale of KOOS with treatment However, it seems that there are differences in the results, not at least as regards the age of the patient

64. Discussion (2) A wedged insole (keel) can be used to start treatment –Easy –Cheap –Sufficient for > 50% of the patients (56 of 90) –Especially for elderly patients –Effect size in elderly similar to meniscectomy

65. Discussion (3) If a wedged insole is insufficient, addition of a brace is beneficial, provided the patient is younger Effect size in the younger patient larger than for meniscectomy

66. Discussion (4) As in other studies of patients with symptoms of OA, female patients score lower values for all items of the KOOS questionnaire

67. Discussion (5) So far unanswered questions: How long will the improvement last? Differences among insole only compared to insole+brace? Will the patients continue to use their insoles/braces What about compliance? How many of these patients will go on having knee arthroplasty in the future?