Opening Wedge High Tibial Osteotomy
- Conditions
- Osteoarthritis, KneeOsteoarthrosis of Knee
- Interventions
- Other: Supervised physiotherapeutic programProcedure: HTO
- Registration Number
- NCT03448796
- Lead Sponsor
- Kuopio University Hospital
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 1
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description FT -group Supervised physiotherapeutic program Group receives only supervised physiotherapeutic rehabilitation. HTO-group HTO Group receives opening wedge high tibial osteotomy with Tomofix -plate. Operative intervention is followed by supervised physiotherapeutic rehabilitation. HTO-group Supervised physiotherapeutic program Group receives opening wedge high tibial osteotomy with Tomofix -plate. Operative intervention is followed by supervised physiotherapeutic rehabilitation.
- Primary Outcome Measures
Name Time Method Change of KOOS5 24, 60, 120 months The change of Composite score of Knee injury and Osteoarthritis Outcome Score (KOOS) subscales
- Secondary Outcome Measures
Name Time Method Change of KOOS subscales 24, 60, 120 months Individual subscales of Knee injury and Osteoarthritis Outcome Scores
Change of pain measured in numeric rated scale (NRS) 24, 60, 120 months Amount of subjective (knee) pain
Change in results of stair climb test 24, 60, 120 months The time (in seconds) it takes to ascend and descend a flight of stairs
Change in mechanical axis of lower limb 12, 24, 60, 120 months As measured from whole leg standing radiograph
Change in results of 40 meter fast paced walk test 24, 60, 120 months A fast-paced walking test that is timed over 4 x 10m (33 ft) for a total 40 m (132 ft)
Radiological progression of arthrosis 24, 60, 120 months x-ray, MRI
Incidence of complications Up to 120 months eg infection, non-union, thromboembolic complications etc.
Total costs of treatment Up to 120 months Including the cost of hospital treatment, physiotherapy, cost of medication, cost of sick leave
15D -quality of life assessement 24, 60, 120 months The change of health-related quality of life (HRQoL) instrument
Change in results of timed up and go test 24, 60, 120 months 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.
Amount of national benefits received Up to 120 months The amount of benefits are gathered from:
1. The hospital discharge register (maintained by National Institute for Health and Welfare)
2. National benefits paid by The Social Insurance Institution of Finland
3. Pension decision made by Finnish Centre for PensionsIncidence of reoperation Up to 120 months Amount of reoperations needed
Synovial fluid composition 24, 60, 120 months 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.General variables reflecting inflammatory status 24, 60, 120 months 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).
Hyaluronic acid (HA) concentration 24, 60, 120 months 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.Fatty acid (FA) profiling 24, 60, 120 months 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-%.
Work Productivity and Activity Impairment Questionnaire (WPAI) 24, 60, 120 months The change of WPAI
Trial Locations
- Locations (1)
University Hospital of Kuopio
🇫🇮Kuopio, Finland