The device subject to this clinical investigation has been developed for treating patients with a history of partial or total meniscectomy, who suffer from symptomatic unicompartmental pain in the meniscus-deficient knee: the post-meniscectomy pain syndrome. The intended purpose of the system is to replace the lateral native meniscus and its function after meniscectomy by distributing tibio-femoral loads and provide a clinically relevant reduction of pain and improvement of joint function.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
16
Implantation of a lateral meniscus prosthesis after meniscectomy.
Radboudumc
Nijmegen, Gelderland, Netherlands
Adverse events
Adverse events within 12 months after implantation.
Time frame: 12 months after implantation.
Implant integrity
Assessed by MRI.
Time frame: 12 months after implantation.
KOOS
KOOS (overall including all subscales) at 6 weeks, 3, 6, 12, 24 months.
Time frame: 24 months.
Lysholm
Lysholm scale at 6 weeks, 3, 6, 12, 24 months.
Time frame: 24 months.
OKS
OKS at 6, 12, 24 months.
Time frame: 24 months.
EQ-5D-5L
EQ-5D-5L at 6, 12, 24 months.
Time frame: 24 months.
WORQ
WORQ at 6 weeks, 3, 6, 12, 24 months.
Time frame: 24 months.
SF-36
SF-36 at 6, 12, 24 months.
Time frame: 24 months.
Likert - Patient satisfaction
Patient satisfaction on a 5-point Likert scale at 6, 12, 24 months.
Time frame: 24 months.
Tegner Activity Scale
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Tegner Activity Scale at 6 weeks, 3, 6, 12, 24 months.
Time frame: 24 months.
IKDC Knee Examination Form
IKDC Knee Examination Form at screening, surgery, 6 weeks, 3, 6, 12, 24 months.
Time frame: 24 months.
Knee X-ray (weight-bearing)
Knee X-ray (weight-bearing) at 6, 12, and 24 months to evaluate the height of the joint space.
Time frame: 24 months.
Knee X-ray (weight-bearing, long-leg)
• Knee X-ray (weight-bearing, long-leg) at 6, 12, and 24 months to evaluate the mechanical axis.
Time frame: 24 months.
Knee X-ray (non-weight-bearing, supine)
Knee X-ray (non-weight-bearing, supine) at 12, and 24 months to evaluate the mechanical axis.
Time frame: 24 months.
Knee MRI (non-weight-bearing)
Knee MRI (non-weight-bearing) at implantation surgery (+(within 1 week, preferably peroperative), 6, 12, and 24 months for implant and joint integrity (cartilage status) assessment (including focal defects, bone marrow lesions, and bone tunnels/fixation sites).
Time frame: 24 months.