Radboudumc
Nijmegen, Gelderland, Netherlands
NCT Number: NCT06705985
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.
Trial opening soon.
Get Notified18 year–70 year
All sexes
Interventional
Not applicable
Nijmegen, Gelderland, Netherlands
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Implantation of a lateral meniscus prosthesis after meniscectomy.
Time frame: 12 months after implantation.
Adverse events within 12 months after implantation.
Time frame: 12 months after implantation.
Assessed by MRI.
Time frame: 24 months.
KOOS (overall including all subscales) at 6 weeks, 3, 6, 12, 24 months.
Time frame: 24 months.
Lysholm scale at 6 weeks, 3, 6, 12, 24 months.
Time frame: 24 months.
OKS at 6, 12, 24 months.
Time frame: 24 months.
EQ-5D-5L at 6, 12, 24 months.
Time frame: 24 months.
WORQ at 6 weeks, 3, 6, 12, 24 months.
Time frame: 24 months.
SF-36 at 6, 12, 24 months.
Time frame: 24 months.
Patient satisfaction on a 5-point Likert scale at 6, 12, 24 months.
Time frame: 24 months.
Tegner Activity Scale at 6 weeks, 3, 6, 12, 24 months.
Time frame: 24 months.
IKDC Knee Examination Form at screening, surgery, 6 weeks, 3, 6, 12, 24 months.
Time frame: 24 months.
Knee X-ray (weight-bearing) at 6, 12, and 24 months to evaluate the height of the joint space.
Time frame: 24 months.
Time frame: 24 months.
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) 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).
Contact information is provided by the study sponsor or research team.
ATRO Medical B.V.
Industry
Treatment of Lateral Knee Joint Pain with Artificial Lateral Meniscus Prosthesis After Meniscectomy
Acronym: EARTH
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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