Osteoarthritis Musculoskeletal Diseases Osteoarthritis
Conditions
Interventions
This is a pragmatic, non-blinded, multi-centre randomised controlled trial designed to establish the clinical and cost-effectiveness of KJD in an NHS setting. 344 participants will be recruited from s
Sponsors
University of Leeds
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Age > = 18 years and < = 65 years at the time of signing the Informed Consent form 2. Symptoms (pain and/or reduced function) severe enough to warrant knee replacement, in the opinion of the treating clinician 3. Pre-operative leg alignment not requiring correction, in the opinion of the treating clinician 4. Intact collateral knee ligaments, in the opinion of the treating clinician 5. Fixed flexion deformity < = 10 degrees of the involved knee
Exclusion criteria
Exclusion criteria: 1. Bone density not sufficient to support pins for 6 weeks, in the opinion of treating clinician 2. Isolated patello-femoral OA, in the opinion of the treating clinician 3. Complete joint space obliteration in both medial and lateral tibio-femoral compartments as seen on weight bearing AP knee radiograph 4. A known diagnosis of inflammatory arthritis 5. Presence of a previous joint replacement in any limb 6. Surgical treatment of involved knee within the past 6 months (excluding arthroscopy) 7. Previous knee joint distraction on the involved knee 8. Previously participated in the KARDS trial 9. Weight > 120kg 10. Pregnant or lactating (confirmed by participant) 11. Active cancer (currently diagnosed and under treatment) 12. Unable to complete all trial procedures (e.g. attend follow up visits, complete questionnaires) 13. Unable to provide informed consent (cognitive disorder such as dementia, psychiatric illness)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Knee Injury & Osteoarthritis Outcomes Score (KOOS) pain component measured at 12 months following surgery | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Patient reported outcomes and Quality of life outcomes (KOOS, Pain VAS, Oxford Knee Score) at baseline and 3, 6, 12, and 24 months after surgery 2. Objective assessment of knee function (Active range of movement and a timed up and go test) at baseline and 3, 12, and 24 months post-surgery 3. Incidence of complications (intra-operative, post-operative and any unplanned surgical interventions on the affected knee) at 3, 12, and 24 months post-surgery 4. Joint space width (assessed quantitatively from standardised radiographs) at 3, 12, and 24 months post-surgery 5. Cost-effectiveness (EQ-5D-3L and Health Resource Utilisation and Private Costs Questionnaire) at 3, 6, 12, and 24 months post-surgery 6. Implementation processes and intervention fidelity (assessed quantitatively using a surgical CRF and assessments of radiographs, and assessed qualitatively) in the first 12 months of recruitment 7. Qualitative evaluation of participant experiences measured using interviews after discharge from hospital and 3 months later | — |
Countries
England, Scotland, United Kingdom
Contacts
Public ContactRachel Kelly
Outcome results
None listed