Safety and Performance of MICRORAPTORâ„¢ Suture Anchors in Shoulder and Hip (NCT03985839) | Clinical Trial Compass
CompletedNot Applicable
Safety and Performance of MICRORAPTORâ„¢ Suture Anchors in Shoulder and Hip
United States299 participantsStarted 2019-08-01
Plain-language summary
This is a prospective, multi-center, PMCF study to evaluate the safety and performance of the MICRORAPTOR REGENESORB suture anchors, MICRORAPTOR Knotless REGENESORB suture anchors, and MICRORAPTOR Knotless PEEK suture anchors implanted in 300 subjects needing reattachment of soft tissue to bone.
Who can participate
Age range12 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Subject requires reattachment of soft tissue to bone for the following indications:
* Shoulder - Capsular stabilization for Bankart repair, Anterior shoulder instability, SLAP lesion repairs, Capsular shift or capsulolabral reconstructions, Biceps tenodesis, Rotator Cuff Repairs (knotless anchors only)
* Hip - Acetabular labrum repair/reconstruction
* Subject has consented to participate in the study by signing the EC-approved informed consent form.
* Subject is ≥18 years of age at time of surgery.
* Willing and able to make all required study visits.
* Able to follow instructions.
Exclusion Criteria:
* Known hypersensitivity to the implant material. Where material sensitivity is suspected, appropriate tests should be made and sensitivity ruled out prior to implantation.
* Pathological conditions of bone, such as cystic changes or severe osteopenia, which would compromise secure anchor fixation.
* Pathological conditions in the soft tissues to be attached that would impair secure fixation by suture.
* Comminuted bone surface, which would compromise secure anchor fixation.
* Physical conditions which would eliminate, or tend to eliminate, adequate anchor support or retard healing.
* The presence of infection.
* Conditions which would limit the subject's ability or willingness to restrict activities or follow directions during the healing period.
* Currently using tobacco products (cigarette, smokeless tobacco, ecigarettes, vaping etc.).
* Concurre…