Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
1 participants
INTERVENTIONAL
2018-05-01
2023-05-10
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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HTO-group
Group receives opening wedge high tibial osteotomy with Tomofix -plate. Operative intervention is followed by supervised physiotherapeutic rehabilitation.
HTO
Group that receives high tibial osteotomy combined with supervised physiotherapy as treatment.
Supervised physiotherapeutic program
Group that receives only supervised physiotherapy as treatment.
FT -group
Group receives only supervised physiotherapeutic rehabilitation.
Supervised physiotherapeutic program
Group that receives only supervised physiotherapy as treatment.
Interventions
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HTO
Group that receives high tibial osteotomy combined with supervised physiotherapy as treatment.
Supervised physiotherapeutic program
Group that receives only supervised physiotherapy as treatment.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
25 Years
55 Years
ALL
No
Sponsors
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Central Finland Hospital District
OTHER
Kuopio University Hospital
OTHER
Responsible Party
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Principal Investigators
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Jussi Jalkanen, M.D.
Role: PRINCIPAL_INVESTIGATOR
Kuopio University Hospital
Locations
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University Hospital of Kuopio
Kuopio, , Finland
Countries
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Other Identifiers
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KUH5203099
Identifier Type: -
Identifier Source: org_study_id
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