A high tibial osteotomy is an effective intervention to treat patients with clinical complaints of medial knee osteoartritis (superiority study) compared to an orthopaedic unloader knee brace.
ID
Bron
Verkorte titel
Aandoening
- Gewrichtsaandoeningen
Aandoening
Knee pain; Knee osteoartritis; Mediale gonartrose
Betreft onderzoek met
Ondersteuning
Onderzoeksproduct en/of interventie
- Chirurgische ingreep
Uitkomstmaten
Primaire uitkomstmaten
knee pain after one year of follow-up
Achtergrond van het onderzoek
Rationale: To postpone joint replacement surgery for patients with uni-compartiment osteoarthritis an osteotomy surgery or an unloader kneebrace are effective treatment options. Till date the effect on symptoms and structural progression of this non-surgical knee brace with the surgical osteotomy has not been compared. Objective: To assess the effects on pain, function, quality of life and structural features with respect to cartilage and subchondral bone of osteotomy surgery after one year of follow-up compared to the effects of treatment with an orthopaedic un-loader knee brace. Study population: Patients, age 18–60, with isolated medial compartment osteoarthritis, concomitant with a varus mechanical axis of the knee, good range of motion and limited ligamentous knee laxity. Intervention: A Randomized Control Trial comparing osteotomy surgery with an orthopaedic un-loader knee brace. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The burden is primarily time (visit of outpatient clinic, and to fill in questionnaires). There is no direct benefit from participation or group relatedness. Osteotomy and non-surgical treatment with an un-loader knee brace are both options in the standard care of active patients, younger than 65, with medial compartment osteoarthritis of the knee.
Doel van het onderzoek
A high tibial osteotomy is an effective intervention to treat patients with clinical complaints of medial knee osteoartritis (superiority study) compared to an orthopaedic unloader knee brace.
Onderzoeksopzet
Baseline, 3, 6, 9, 12 and 24 months
Onderzoeksproduct en/of interventie
Publiek
P.O. Box 1738
S. Bierma-Zeinstra
Rotterdam 3000 DR
The Netherlands
+31 (0)10-4087633
s.bierma-zeinstra@erasmusmc.nl
Wetenschappelijk
P.O. Box 1738
S. Bierma-Zeinstra
Rotterdam 3000 DR
The Netherlands
+31 (0)10-4087633
s.bierma-zeinstra@erasmusmc.nl
Leeftijd
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
- age 18 - 65 - medial knee pain > 3 months - NRS score > 3 - radiographic signs of medial knee osteoartritis - varus malalignment > 0° en ≤14°
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
- Lateral compartment with Kellgren & Lawrence ≥ grade 2 - contraindication to one of the two interventions - rheumatoid arthritis - grade-3 collateral ligament laxity - a flexion contracture of > 10° - range of motion of < 100° - fracture or previous open operation of the lower limb - patients with a contralateral high tibial osteotomy will be excluded if the first knee has been included in this trial - patients that already used an orthopaedic knee brace for knee OA in the same knee - patients from whom it is not sure that they will be able to attend the follow-up measurements - insufficient command of the Dutch language, spoken and/or written
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL4200 |
| NTR-old | NTR4411 |
| CCMO | NL45685.078.13 |
| OMON | NL-OMON44769 |