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
Source
Brief title
Condition
- Joint disorders
Synonym
Health condition
Knee pain; Knee osteoartritis; Mediale gonartrose
Research involving
Sponsors and support
Intervention
- Surigical procedure
Outcome measures
Primary outcome
knee pain after one year of follow-up
Secondary outcome
1. Patient Reported Outcomes: pain severity, function, quality of life, physical activity and patient satisfaction; 2. Change in structural features with respect to cartilage and subchondral bone; 3. Adverse events; 4. Pain medication use; 5. Direct and indirect costs.
Background summary
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.
Study objective
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.
Study design
Baseline, 3, 6, 9, 12 and 24 months
Intervention
- 28 patients will receive a high tibial osteotomy - 28 patients will receive an unloader brace
P.O. Box 1738
S. Bierma-Zeinstra
Rotterdam 3000 DR
The Netherlands
+31 (0)10-4087633
s.bierma-zeinstra@erasmusmc.nl
P.O. Box 1738
S. Bierma-Zeinstra
Rotterdam 3000 DR
The Netherlands
+31 (0)10-4087633
s.bierma-zeinstra@erasmusmc.nl
Age
Inclusion criteria
- age 18 - 65 - medial knee pain > 3 months - NRS score > 3 - radiographic signs of medial knee osteoartritis - varus malalignment > 0° en ≤14°
Exclusion criteria
- 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
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL4200 |
| NTR-old | NTR4411 |
| CCMO | NL45685.078.13 |
| OMON | NL-OMON44769 |