Status:
NOT_YET_RECRUITING
Grip on Knee Osteoarthritis; DIstraction Versus Arthroplasty
Lead Sponsor:
UMC Utrecht
Conditions:
Knee Osteoarthritis
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
The goal of this pragmatic, open, (1:1) randomized, multi-centre, non-inferiority trial is to to determine whether knee-joint distraction (KD) is non-inferior on patient reported effectiveness as comp...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Clinical diagnosis of knee OA
- Age ≤ 65 years and ≥ 18 years
- Persistent, refractory pain, insufficiently responding to conservative or previous surgical therapy
- Structural OA joint damage, indicated by a K\&L grade of at least 2 as determined by the orthopedic surgeon in line with NOV recommendations.
- Able to wear an external fixator and care for it for 6 weeks
- Accepting that the maximal effect of KJD is not present directly after removal of the frame but may take months after frame removal
- Sufficient joint stability (according to the orthopedic surgeon's judgement)
- Flexion (\>100 degrees) and extension range (\<10 degrees)
- Weight and BMI \<120 kg and \<35 kg/m2, respectively
- Sufficient understanding of the Dutch language
- Signed informed consent
- Exclusion criteria:
- Surgical intervention in last 6 months
- Leg-axis deviation \> 10 degrees (as determined by the orthopedic surgeon)
- Serious osteopenia making placing bone-pins and wearing a frame into a risk (according to the orthopedic surgeon's judgement)
- Coagulation problems making occurrence of thrombosis or embolies into a risk (according to the orthopedic surgeon's judgement)
- Existing endoprosthesis at any other joint (e.g. hip or contralateral knee) to prevent infection of existing prosthesis
- History or presence of joint infection/inflammation
- Hypersensitivity to antibiotics
- Presence of systemic inflammatory disease, like rheumatoid arthritis
Exclusion
Key Trial Info
Start Date :
December 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2028
Estimated Enrollment :
600 Patients enrolled
Trial Details
Trial ID
NCT06113549
Start Date
December 1 2023
End Date
June 1 2028
Last Update
November 7 2023
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