Opening Wedge High Tibial Osteotomy

Study Overview
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Brief Summary
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A prospective, randomised controlled trial where clinical and radiological outcome of high tibial opening wedge osteotomy with physiotherapy is compared to physiotherapy alone while treating symptomatic medial knee osteoarthrosis.

Detailed Description
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90 Symptomatic patients with mild to moderate medial knee osteoarthrosis are randomized to two groups: Group 1 (HTO-group) receive an diagnostic arthroscopy with high tibial opening wedge osteotomy (Tomofix-plate). Postoperatively a supervised physiotherapeutic rehabilitation program is started. Group 2 (FT-group) receive the same supervised physiotherapeutic rehabilitation program without the HTO or arthroscopy. Primary outcome measure is composite score of Knee injury and Osteoarthritis Outcome Score (KOOS5). Secondary outcome measures are pain (VAS), KOOS subscales, objective physical performance measurements, progression of osteoarthrosis (X-ray, MRI), change of mechanical axis, complications, treatment costs, rate of reoperation, revision to total knee arthroplasty (TKA), biological markers of arthrosis progression, 15D (quality of life assessment), QALY (Quality-Adjusted Life-Year), Work Productivity and Activity Impairment Questionnaire, Work Productivity and Activity Impairment Questionnaire, sum of governmental benefits received. Outcomes will be measured at 24, 60 and 120 months after the intervention.

Official Title
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High Tibial Opening Wedge Osteotomy and Conservative Treatment in Medial Knee Osteoarthritis - A Randomised Controlled Trial

Conditions
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Osteoarthrosis of Knee, Osteoarthritis, Knee

Intervention / Treatment
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* Procedure: HTO
* Other: Supervised physiotherapeutic program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pain: Subjective pain in the knee most of the month for at least one month during past 12 months. Knee range of motion (ROM) at least 5-120 degrees X-ray: medial joint space Altman > 1. Lateral joint space Altman < 2. Mechanical axis > 3 degrees varus alignment. Medial proximal tibial angle (MPTA) < 90 degrees age 25-55. Written consent, accepts both treatment arms. Exclusion Criteria: Pain is caused by something else than medial knee osteoarthrosis deficient ROM (flexion contracture > 10 degrees, flexion < 110 degrees) significant ligament instability post traumatic OA clinically relevant neurological disease (e.g. Alzheimer´s disease) clinically relevant metabolical disease (e.g. Diabetes) alcohol/drug abuse infectious/inflammatory joint disease previous knee area osteotomy or lower limb arthroplasty smoking (> 0 cigarette per day) obesity (BMI > 33) pregnancy or hope of pregnancy in the following two years

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective randomized controlled trial.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: HTO-group<br>Group receives opening wedge high tibial osteotomy with Tomofix -plate. Operative intervention is followed by supervised physiotherapeutic rehabilitation. | Procedure: HTO<br>* Group that receives high tibial osteotomy combined with supervised physiotherapy as treatment.<br>Other: Supervised physiotherapeutic program<br>* Group that receives only supervised physiotherapy as treatment.<br>|
| Active Comparator: FT -group<br>Group receives only supervised physiotherapeutic rehabilitation. | Other: Supervised physiotherapeutic program<br>* Group that receives only supervised physiotherapy as treatment.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of KOOS5 | The change of Composite score of Knee injury and Osteoarthritis Outcome Score (KOOS) subscales | 24, 60, 120 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of pain measured in numeric rated scale (NRS) | Amount of subjective (knee) pain | 24, 60, 120 months | 
| Change of KOOS subscales | Individual subscales of Knee injury and Osteoarthritis Outcome Scores | 24, 60, 120 months | 
| Change in results of 40 meter fast paced walk test | A fast-paced walking test that is timed over 4 x 10m (33 ft) for a total 40 m (132 ft) | 24, 60, 120 months | 
| Change in results of stair climb test | The time (in seconds) it takes to ascend and descend a flight of stairs | 24, 60, 120 months | 
| Change in results of timed up and go test | Time (seconds) taken to rise from a chair, walk 3 m, turn, walk back to the chair, then sit down wearing regular footwear and using a walking aid if required. | 24, 60, 120 months | 
| Radiological progression of arthrosis | x-ray, MRI | 24, 60, 120 months | 
| Change in mechanical axis of lower limb | As measured from whole leg standing radiograph | 12, 24, 60, 120 months | 
| Incidence of complications | eg infection, non-union, thromboembolic complications etc. | Up to 120 months | 
| Total costs of treatment | Including the cost of hospital treatment, physiotherapy, cost of medication, cost of sick leave | Up to 120 months | 
| Incidence of reoperation | Amount of reoperations needed | Up to 120 months | 
| Hyaluronic acid (HA) concentration | At 24, 60 and 120 month follow-up blood and synovial fluid samples are analyzed for HA concentration. This will be measured with antibody-ELISA at mg/g from 10µl of fluid. The same measurement will be conducted on blood serum. | 24, 60, 120 months | 
| Fatty acid (FA) profiling | At 24, 60 and 120 month follow-up blood and synovial fluid samples are analyzed for fatty acid (FA) profiling. FA will be analyzed from 75 µl of synovial fluid and 200 µl of blood serum with gas chromatography as mol-%. | 24, 60, 120 months | 
| Synovial fluid composition | At 24, 60 and 120 month follow-up synovial fluid samples are analyzed for composition. Synovial fluid composition will be assessed visually with confocal microscopy with a HA-biding fluorescent probe and Nile red probe that show both HA particles and the association of these particles on extracellular vesicles to assess the significance of vesicle-mediated HA secretion into synovial fluid. | 24, 60, 120 months | 
| General variables reflecting inflammatory status | At 24, 60 and 120 month follow-up blood and blood serum samples are analyzed for general variables reflecting inflammatory status (leucocytes, C-reactive protein, IL-6). | 24, 60, 120 months | 
| 15D -quality of life assessement | The change of health-related quality of life (HRQoL) instrument | 24, 60, 120 months | 
| Work Productivity and Activity Impairment Questionnaire (WPAI) | The change of WPAI | 24, 60, 120 months | 
| Amount of national benefits received | The amount of benefits are gathered from: The hospital discharge register (maintained by National Institute for Health and Welfare) National benefits paid by The Social Insurance Institution of Finland Pension decision made by Finnish Centre for Pensions | Up to 120 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Osteoarthrosis, High tibial osteotomy, Tomofix, Randomized controlled trial