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Knee OA
Evaluation of treatment with orthotics
(wedged insole and knee brace)
Preliminary data
Kjell G Nilsson, MD, PhD, FRACSJan Karlsson, CPO
Department of OrthopaedicsUmeå University hospital
Umeå, Sweden
Implant Research Unit
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
30 40 50 60 70 800
10
20
30
40
50
60
70
80
90
Age
Hip OA
Knee OA
Finger OA
Prevalence of OA (%)
Implant Research Unit
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
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
Implant Research Unit
Treatment of OA
Few
Some
All
?
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
Wedged insole
Suggested function Reduce the load (varus moment) lateral keel reduce pain
Suggested function
Reduce the load
(varus moment)
keel + valgusbrace
(three point pinciple)
reduce pain
Wedged insole + brace
Treatment of knee OA with orthotics
• Several studies have shown biomechanical effects of wedged insoles and knee braces
But
• What about their clinical effects??
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?
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 2003:1:64Roos, Roos, Lohmander et al, Scand J Med Sci Sports 1998:8:439Roos, Roos, Lohmander et al, J Orthop Sports Phys Ther 1998:28:88
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
KOOS
• Change over time “Effect Size”
(After – Before)/SD (Before)
Before treatment
After treatment
After
Before
Arthroplasty ACL reconstr Meniscectomy ACI
0.0
0.5
1.0
1.5
2.0
2.5
3.0
painsymptomsADLSportsRecrQoL
Effect size, examples
Present Study
1. Initially, offer all patients a laterally or medially wedged insoleFollow up minimum 6 weeks
2. For those who are unsatisfied with insole, offer a knee brace in addition to insoleFollow up minimum 6 weeks
3. (Plan: Continued follow up of all patients > 5 years)
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…)
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
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
Patient logistics (2)
136 referralsreceived
120 KOOS formscorrectly filled out
90 KOOS formsreceived after 6 weeks
treatment with insole/keel
Insole/keel treatment
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
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)
Inlay sole:10° laterally or medially based keel
Braces used
Custom CarbonFibre
1 patient
DonJoy (11-0872)
1 patient
Camp (Breg 0700, Breg 25262)
8 patients
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
Össur Unloader One
24 patients
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)
Preliminary data
Effect of a wedged insole
Pain Symptoms ADL Sports QoL
100
80
60
40
20
0
Pre
Keel
0.05 ns ns ns 0.003
Insole/Keel (90 patients)
Paired t test
Mean values ± 95% CI
Pain Symptoms ADL Sports QoL
100
80
60
40
20
0
Pre
Keel
ns ns ns ns ns
Insole/Keel(women)
Paired t test
Mean values ± 95% CI
Pain Symptoms ADL Sports QoL
100
80
60
40
20
0
Pre
Keel
0.01 ns ns ns 0. 002
Insole/Keel(men)
Paired t test
Mean values ± 95% CI
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)
Keel all Keel women Keel men
0.0
0.2
0.4
0.6
0.8
1.0
painsymptomsADLSportsRecrQoL
Pain Symptoms ADL Sports QoL
100
80
60
40
20
0
Men Pre
Men Keel
Women Pre
Women Keel
Women vs menw and w/o insole/keel
0.02 0.006 0.04 0.17 0.45Women keel vs men keel
0.17 0.004 0.09 0.11 0.81Women pre vs men pre
Un-paired t test
Effects of insole/keel and age
Pain Symptoms ADL Sports QoL
100
80
60
40
20
0
Pre
Keel
ns ns ns ns ns
Insole/Keel(age < 60 years)
Paired t test
Mean values ± 95% CI
Pain Symptoms ADL Sports QoL
100
80
60
40
20
0
Pre
Keel
0.04 ns 0.04 ns 0.001
Insole/Keel(age > 60 years)
Paired t test
Mean values ± 95% CI
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)
Keel young Keel old
0.0
0.2
0.4
0.6
0.8
1.0
painsymptomsADLSportsRecrQoL
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?
Pain Symptoms ADL Sports QoL
100
80
60
40
20
0
Satisfied vs dissatisfied after 6w with insole/keel
56 Satisfied with keel
34 Dissatisfied with keel
0.02 0.28 0.08 0.71 0.02 Un-paired t test
Effects of insole/keel and brace
Pain Symptoms ADL Sports QoL
100
80
60
40
20
0
Pre
Keel + orthosis
0.9 0.02 0.048 0.04 0.01
Keel + Brace (34 patients)
Paired t test
Mean values ± 95% CI
Pain Symptoms ADL Sports QoL
100
80
60
40
20
0
Pre
Keel + orthosis
0.29 0.32 0.30 0.53 0.54
Keel + Brace (34 patients)
Effect Size:
Summary: Effects of Keel and Brace
• Significant improvement of all 5 subscales of KOOS– Effect size 0.29 (pain) to 0.54 (QoL)
Effects of keel and braceand age
Pain Symptoms ADL Sports QoL
100
80
60
40
20
0
Pre
Keel + orthosis
0.04 0.01 0.01 0.01 0.002
Keel + Brace (< 60 years)
Paired t test
Mean values ± 95% CI
Pain Symptoms ADL Sports QoL
100
80
60
40
20
0
ns ns ns ns ns
Pre
Keel + orthosis
Keel + Brace (> 60 years)
Paired t test
Mean values ± 95% CI
Keel+Brace young Keel+Brace old
0.0
0.2
0.4
0.6
0.8
1.0
painsymptomsADLSports/RecrQoL
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
Effect size, examples
MeniscectomyKeel old
Keel youngKeel+Brace old
Keel+Brace young
0.0
0.2
0.4
0.6
0.8
painsymptomsADLSportRecrQoL
Keel+Brace old
Effect size summary
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
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
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
Discussion (4)
• As in other studies of patients with symptoms of OA, female patients score lower values for all items of the KOOS questionnaire
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?