NCT04552119已完成不适用
Prospective, Multi-Center, Post-Market Clinical Follow-up Study to Evaluate Safety and Performance of the HEALICOIL™ Knotless Suture Anchor in Shoulder Rotator Cuff Tendon Repair
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 138
- 试验地点
- 10
- 主要终点
- Repair failure rate of HEALICOIL Knotless Suture Anchors
研究概览
简要总结
This study evaluates the safety of the HEALICOIL Knotless Suture Anchors in patients requiring a repair of the rotator cuff tendon repair
详细描述
This is a multicenter, prospective, post-marketing, observational, case series study to evaluate the safety and efficacy of the HEALICOIL Knotless Suture Anchors in subjects with either rotator cuff repair and/or biceps tenodesis. Approximately 160 subjects will be enrolled at up to 6 sites. Safety monitoring will include documentation device- and surgery-related AEs. Efficacy will be monitored by assessment of post-operative follow up, clinical complications, reoperation rate, EQ-5D-5L, and pain VAS.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Requires reattachment of soft tissue to bone for the following shoulder indications:
- •Rotator Cuff Tendon repair:
- •i. Single or double row rotator cuff repair using HEALICOIL Knotless PEEK NST, HEALICOIL Knotless PEEK Self-Tapping, or HEALICOIL Knotless RG Self-Tapping; OR
- •ii. Double row rotator cuff repair using HEALICOIL Knotless RG NST in lateral row (existing HEALICOIL RG device to be used in medial row of the repair); AND/OR
- •Biceps tenodesis
- •i. In conjunction with Rotator Cuff Tendon repair using HEALICOIL Knotless PEEK NST, HEALICOIL Knotless PEEK Self-Tapping, HEALICOIL Knotless RG NST or HEALICOIL Knotless RG Self-Tapping OR
- •ii. As a stand-alone procedure for HEALICOIL Knotless PEEK NST, HEALICOIL Knotless PEEK Self-Tapping, or HEALICOIL Knotless RG Self-Tapping (not HEALICOIL Knotless RG NST
- •Has a pre-operative MRI collected within 6 months of surgery which meets one of the following criteria:
- •MRI collected as standard-of-care has been submitted to external imaging vendor and confirmed as acceptable OR
- •If standard-of-care images are unavailable or considered unacceptable by external imaging vendor, subject must undergo an additional study-specific pre- operative MRI, confirmed as acceptable by external imaging vendor OR
- •MRI not required; subject not in HEALICOIL Knotless RG NST subgroup
- •Has consented to participate in the study by signing the IRB/IEC approved informed consent form.
- •Requires only one variant of the HEALICOIL Knotless Suture Anchor
- •Is ≥18 years of age at time of surgery
- •Willing and able to make all required study visits
- •Able to follow instructions (Approved translated documents supplied upon request)
排除标准
- •Any one (1) of the following criteria will disqualify a potential subject from participation in the study:
- •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.
- •Concurrent bilateral surgery.
- •Participation in the treatment period of another clinical trial within thirty (30) days of Visit 1, or during the study.
- •Women who are pregnant.
- •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
HEALICOIL Knotless REGENESORB
HEALICOIL™ Knotless Suture Anchor in Shoulder Rotator Cuff Tendon Repair using HEALICOIL Knotless REGENESORB
干预措施: HEALICOIL Knotless REGENESORB (Device)
HEALICOIL Knotless PEEK
HEALICOIL™ Knotless Suture Anchor in Shoulder Rotator Cuff Tendon Repair using HEALICOIL Knotless PEEK
干预措施: HEALICOIL Knotless PEEK (Device)
结局指标
主要结局
Repair failure rate of HEALICOIL Knotless Suture Anchors
时间窗: 6 months
Repair failure rate defined as the need for a second repair procedure at 6 months.
Clinical Success Rate at 6 Months
时间窗: 6 months
Clinical success was identified by the repair failure rate defined as the need for a second repair procedure. The second repair procedure would be a repair of the original rotator cuff and/or biceps tenodesis from the index procedure.
次要结局
- Repair failure rate at 12 months and 24 months(12 and 24 months)
- Single Assessment Numeric Evaluation (SANE) Shoulder scale at 6 months and 12 months(6 and 12 months)
- Constant-Murley Score(6, 12, and 24 months)
- EQ-5D-3L at 6 months and 12 months(6 and 12 months)
- Tendon thickening and anchor absorption/replacement by bone at 6 months and 24 months for HEALICOIL Knotless REGENESORB Non-Self Tapping(6 and 24 months)
- American Shoulder and Elbow Surgeons (ASES) Visual Analog Scale (VAS) pain score(6, 12, and 24 months)
- Tendon re-tear rate at 6 months and 24 months for HEALICOIL Knotless REGENESORB Non-Self Tapping only(6 and 24 months)
- Clinical Success Rate at 12 Months(12 months)
- Clinical Success Rate at 24 Months (HEALICOIL Knotless REGENESORB Non-Self Tapping Suture Anchor ONLY)(24 months)
- Constant-Murley Score(Baseline, 6 months, 12 months, and 24 months)
- American Shoulder and Elbow Surgeons (ASES) Score(Baseline, 6 months, 12 months, and 24 months)
- American Shoulder and Elbow Surgeons (ASES): Visual Analog Scale (VAS) Pain Score(Baseline, 6 months, 12 months, and 24 months)
- Single Assessment Numeric Evaluation (SANE) Shoulder Scale at 6 Months and 12 Months(Baseline, 6 months, 12 months, and 24 months)
- EuroQol (European Quality of Life) Five-dimensional Three-level (EQ-5D-3L): Index Score(Baseline, 6 months, 12 months, and 24 months)
- EuroQol (European Quality of Life) Five-dimensional Three-level (EQ-5D-3L): Visual Analogue Scale (VAS) Score(Baseline, 6 months, 12 months, and 24 months)
- Tendon Thickening at 6 Months and 24 Months (HEALICOIL Knotless REGENESORB Non-Self Tapping ONLY)(6 months and 24 months)
- Tendon Re-tear Status at 6 Months and 24 Months (HEALICOIL Knotless REGENESORB Non-Self Tapping ONLY)(6 months and 24 months)
研究者
研究点 (10)
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