Status:
NOT_YET_RECRUITING
RSA Restoris MultiCompartmental Knee
Lead Sponsor:
Reinier Haga Orthopedisch Centrum
Conditions:
Osteoarthritis, Knee
Eligibility:
All Genders
18+ years
Brief Summary
Patients with isolated medial compartment arthritis of the knee are commonly treated with unicompartmental knee arthroplasty (UKA). In contrast with total knee arthroplasty (TKA), UKA shows a higher r...
Eligibility Criteria
Inclusion
- Indication for medial unicompartmental knee replacement as described in the manufacturer's guideline, namely as a result of moderately disabling joint disease of the knee resulting from:
- Painful osteo- or post-traumatic arthritis
- As an alternative to tibial osteotomy
- Age \> 18 years
- Patient qualified for UKP based on physical exam and medical history
- Patient is able to speak and write Dutch
- Patient is willing to participate
- Patient is able and willing to provide written informed consent
Exclusion
- Contraindication as described by the manufacturer:
- Inflammatory arthritis or tricompartmental disease
- Greater than 10 degrees of hyperextension
- Greater than 10 degrees of varus or valgus deformity
- Presence of infection (including history of infection), acute or chronic, local or systematic
- Either mental or neuromuscular disorders that do not allow control of the knee joint
- Insufficient bone stock to allow appropriate insertion and fixation of the prosthesis
- Insufficient soft tissue integrity to provide adequate stability
- Insufficient articulation of the hip joint
- Metal in the operative or non-operative leg which lead to the creation of accuracy-reducing artefacts in the CT scan
- Insufficient bone quality to provide adequate stability
- Loss of ligament structures to prevent creation of an ideal intra-operative plan
- Patients has a known or suspected sensitivity or allergy to one or more of the implant materials
- Revision UKP surgery of the same compartment
Key Trial Info
Start Date :
June 1 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 1 2029
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT05417984
Start Date
June 1 2022
End Date
June 1 2029
Last Update
June 14 2022
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