An interventional study of HTO and Supervised physiotherapeutic program in Osteoarthrosis of Knee and Osteoarthritis, Knee, sponsored by Kuopio University Hospital. Terminated at 1 site in Finland. Open to participants aged 25 Years to 55 Years. Per ClinicalTrials.gov, last updated 2023-10-27.
Sponsored by Kuopio University Hospital · Not applicable, Interventional, and Treatment
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.
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.
Exclusion Criteria:
Group receives opening wedge high tibial osteotomy with Tomofix -plate. Operative intervention is followed by supervised physiotherapeutic rehabilitation.
Procedure: HTO · Other: Supervised physiotherapeutic program
Group receives only supervised physiotherapeutic rehabilitation.
Other: Supervised physiotherapeutic program
Group that receives high tibial osteotomy combined with supervised physiotherapy as treatment.
Group that receives only supervised physiotherapy as treatment.
Change of KOOS5
The change of Composite score of Knee injury and Osteoarthritis Outcome Score (KOOS) subscales
Time frame: 24, 60, 120 months
Change of pain measured in numeric rated scale (NRS)
Amount of subjective (knee) pain
Time frame: 24, 60, 120 months
Change of KOOS subscales
Individual subscales of Knee injury and Osteoarthritis Outcome Scores
Time frame: 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)
Time frame: 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
Time frame: 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.
Time frame: 24, 60, 120 months
Radiological progression of arthrosis
x-ray, MRI
Time frame: 24, 60, 120 months
Change in mechanical axis of lower limb
As measured from whole leg standing radiograph
Time frame: 12, 24, 60, 120 months
Incidence of complications
eg infection, non-union, thromboembolic complications etc.
Time frame: Up to 120 months
Total costs of treatment
Including the cost of hospital treatment, physiotherapy, cost of medication, cost of sick leave
Time frame: Up to 120 months
Incidence of reoperation
Amount of reoperations needed
Time frame: 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.
Time frame: 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-%.
Time frame: 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.
Time frame: 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).
Time frame: 24, 60, 120 months
15D -quality of life assessement
The change of health-related quality of life (HRQoL) instrument
Time frame: 24, 60, 120 months
Work Productivity and Activity Impairment Questionnaire (WPAI)
The change of WPAI
Time frame: 24, 60, 120 months
Amount of national benefits received
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 Pensions
Time frame: Up to 120 months
Plan to share: Undecided
No publications or documents are linked to this record.
This study is terminated, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.
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Kuopio University Hospital