Prospective Multi-Center Post-Market Clinical Follow-up Study to Evaluate Safety and Performance of the MICRORAPTOR REGENESORB, Knotless REGENESORB and Knotless PEEK Suture Anchors (and MINITAPE Sutures) in Shoulder and Hip Arthroscopic Instability Repair
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 298
- 试验地点
- 22
- 主要终点
- Repair failure rate
研究概览
简要总结
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 315 subjects needing reattachment of soft tissue to bone.
详细描述
The purpose of this trial is to assess, by product, safety and performance post-market of the Microraptor Regenesorb, Microraptor Knotless Regenesorb, and Microraptor Knotless PEEK Suture Anchors.
Approximately 18 sites (approximately 3 sites for study shoulder group and 3 sites for study hip group, per product) in the United States will participate in the study. This is an open-label study with consecutive enrollment. The study will continue for 24 months from the date that the last subject received the study treatment to the date that the last subject completes the study as planned. The study duration is planned for 36 months.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject requires reattachment of soft tissue to bone for one of the following indications:
- •Shoulder - Capsular stabilization for Bankart repair, anterior shoulder instability, superior labrum from anterior to posterior (SLAP) lesion repairs, capsular shift or capsulolabral reconstructions; biceps tenodesis (knotless anchors only)
- •Hip - Acetabular labrum repair/reconstruction
- •Subject if ≥ 18 years of age or legally authorized representative if subject is <18 years of age has consented to participate in the study by signing the IRB approved informed consent form. If <18 years of age, subject has assented to participate in the study by signing the IRB approved assent form.
- •Subject is ≥12 years of age at time of surgery.
- •Willing and able to make all required study visits.
- •Able to follow instructions.
排除标准
- •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, e-cigarettes, vaping etc.).
- •Concurrent bilateral surgery.
- •Prior MICRORAPTOR™ REGENESORB™, MICRORAPTOR™ Knotless REGENESORB™ or MICRORAPTOR™ Knotless PEEK implantation.
- •Participation in the treatment period of another clinical trial within thirty (30) days of Visit 1, or during the study.
- •Women who are pregnant or nursing.
- •History of poor compliance with medical treatment.
- •Prior ipsilateral surgeries performed on the joint space.
- •Subjects with a medical or physical condition that, in the opinion of the Investigator, would preclude safe subject participation in the study.
研究组 & 干预措施
MICRORAPTOR™ REGENESORB™ Suture Anchor
MICRORAPTOR™ REGENESORB™ Suture Anchor
干预措施: MICRORAPTOR™ REGENESORB™ Suture Anchor (Device)
MICRORAPTOR™ Knotless REGENESORB™ Suture Anchor
MICRORAPTOR™ Knotless REGENESORB™ Suture Anchor
干预措施: MICRORAPTOR™ Knotless REGENESORB™ Suture Anchor (Device)
MICRORAPTOR™ Knotless PEEK Suture Anchor
MICRORAPTOR™ Knotless PEEK Suture Anchor
干预措施: MICRORAPTOR™ Knotless PEEK Suture Anchor (Device)
结局指标
主要结局
Repair failure rate
时间窗: 6 months
To assess repair failure rate at 6 months
Repair Failure Rate at 6 Months
时间窗: 6 months
Repair failure at 6 months was determined by physician diagnosis of recurrent shoulder dislocation, subluxation, and patient symptoms (e.g., pain). In the event of suspected repair failure, MRI or CT scan must confirm the root cause (i.e., intraarticular labrum failure or fixation repair failure) and assess glenoid bone loss. The repair failure rate was defined as the number of participants with confirmed repair failure divided by the total number of participants in the study device group at the 6-month follow-up.
次要结局
- Anchor absorption/replacement by bone (Knotless Regenesorb only)(6 and 24 months)
- ROWE shoulder score(6 and 12 months)
- HOS-ADL Score(6 and 12 months)
- Modified Harris Hip Score(6 and 12 months)
- WOSI shoulder score(6 and 12 months)
- Constant-Murley Shoulder Scale(6 and 12 months)
- Repair failure rate(12 months)
- Adverse Events (AEs)(12 months)
- Repair Failure Rate at 12 Months(12 months)
- Visual Analogue Scale (VAS) Pain Change From Baseline(Baseline to 6 months, 12 months, and 24 months)
- Repair Failure Rate at 24 Months (MICRORAPTOR™ Knotless REGENESORB™ Suture Anchor ONLY)(24 months)
- Anchor Absorption/Replacement by Bone (MICRORAPTOR™ Knotless REGENESORB™ Suture Anchor ONLY): Acetabular Labral Condition(Baseline, 6 months, and 24 months)
- Anchor Absorption/Replacement by Bone (MICRORAPTOR™ Knotless REGENESORB™ Suture Anchor ONLY): Joint Effusion(Baseline, 6 months, and 24 months)
- Anchor Absorption/Replacement by Bone (MICRORAPTOR™ Knotless REGENESORB™ Suture Anchor ONLY): Bone Marrow Edema(Baseline, 6 months, and 24 months)
- Rowe Shoulder Score Change From Baseline (Shoulder Participants ONLY)(Baseline to 6 months, 12 months, and 24 months)
- Western Ontario Shoulder Instability Index (WOSI) Score Change From Baseline (Shoulder Participants ONLY)(Baseline to 6 months, 12 months, and 24 months)
- Constant-Murley Shoulder Scale Change From Baseline (Should Participants ONLY)(Baseline to 6 months, 12 months, and 24 months)
- Hip Outcome Score Activities of Daily Living (HOS-ADL) Score Change in Baseline (Hip Participants ONLY)(Baseline to 6 months, 12 months, and 24 months)
- Modified Harris Hip Score (mHHS) Change From Baseline (Hip Participants ONLY)(Baseline to 6 months, 12 months, and 24 months)