Osteoarthritis, Knee, Osteoarthrosis of Knee
Conditions
Keywords
High tibial osteotomy, Osteoarthrosis, Tomofix, Randomized controlled trial
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.
Interventions
PROCEDUREHTO
Group that receives high tibial osteotomy combined with supervised physiotherapy as treatment.
OTHERSupervised physiotherapeutic program
Group that receives only supervised physiotherapy as treatment.
Sponsors
Central Finland Hospital District
Kuopio University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
The clinical assessors are blinded when applicable.
Intervention model description
Prospective randomized controlled trial.
Eligibility
Sex/Gender
ALL
Age
25 Years to 55 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of KOOS5 | 24, 60, 120 months | The change of Composite score of Knee injury and Osteoarthritis Outcome Score (KOOS) subscales |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change of pain measured in numeric rated scale (NRS) | 24, 60, 120 months | Amount of subjective (knee) pain |
| Change of KOOS subscales | 24, 60, 120 months | Individual subscales of Knee injury and Osteoarthritis Outcome Scores |
| 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) |
| 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 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. |
| Radiological progression of arthrosis | 24, 60, 120 months | x-ray, MRI |
| Change in mechanical axis of lower limb | 12, 24, 60, 120 months | As measured from whole leg standing radiograph |
| Incidence of complications | Up to 120 months | eg infection, non-union, thromboembolic complications etc. |
| 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 Pensions |
| Incidence of reoperation | Up to 120 months | Amount of reoperations needed |
| 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-%. |
| 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). |
| 15D -quality of life assessement | 24, 60, 120 months | The change of health-related quality of life (HRQoL) instrument |
| Work Productivity and Activity Impairment Questionnaire (WPAI) | 24, 60, 120 months | The change of WPAI |
| Total costs of treatment | Up to 120 months | Including the cost of hospital treatment, physiotherapy, cost of medication, cost of sick leave |
Countries
Finland
Outcome results
None listed