Evaluation of the Safety and Performance of the Lok™ Suture Anchors Range and Associated Instrumentation - Multicenter Interventional and Single Blind Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 216
- 试验地点
- 1
- 主要终点
- Constant score
研究概览
简要总结
The aim of this study is to evaluate the performance and safety of Move-Up's lok™ system (lok™ suture anchors range and associated instrumentation). These devices will be evaluated at approximately 3, 6 and 12 months with 3 scoring criteria: Constant score, VAS pain score, and subjective shoulder value score (SSV). At the 6-month and 12-month post-operative visit, tendon healing, and the absence of recurrence of rupture or failure to heal in patients treated with lok™ anchors will also be analyzed.
The Sugaya score on ultrasound imaging will be used for this assessment. Adverse Events (AEs) and Serious Adverse Events (SAEs) will be assessed after the surgery and at each follow-up (1, 3, 6 and 12 months after the surgery).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
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
- •Consent to participate in the study: oral and written.
- •Man or woman over 18 years old with bone maturity finished.
- •Presented with one of the following indications:
- •Rotator cuff lesion (tear or calcific tendinopathy) associated to a pathology of the long head of the biceps,
- •Gleno-humeral instability,
- •partial articular-sided tendon avulsion [PASTA] lesion.
- •MRI or arthrogram proving the rotator cuff lesion and long head of the biceps tendon injury, or the labrum injury, or PASTA injury.
- •Non inclusion Criteria:
- •Radiographic sign of fracture: glenoid or lesser tuberosity.
- •Major trauma to the shoulder joint.
- •Any active infection or avascular necrosis.
- •Inflammatory joint disease.
- •Moderate to severe degenerative glenohumeral arthropathy (Kellgren-Lawrence Grade 3 or 4).
- •Bone pathologies compromising anchorage (cystic changes, severe osteopenia).
- •Pathological conditions of soft tissues impairing suture fixation.
- •Known hypersensitivity to implant material (PEEK and carbon or Polyethylene).
- •Anterior ipsilateral surgeries performed on the joint space.
- •Physical conditions that would eliminate, or tend to eliminate, adequate anchoring support or delay healing.
- •Contraindications from the instructions for use of the medical devices used.
- •Conditions that would limit the subject's ability or willingness to restrict activities or follow instructions during the healing period.
- •Inability to complete questionnaires: language problems, who do not speak/read/understand French.
- •Pregnant or breastfeeding women.
- •Persons deprived of liberty or under guardianship.
- •Patients unable to undergo medical monitoring of the trial.
- •Psychiatric illnesses, cognitive disorders, or health problems that prevent informed consent.
- •Participation in another clinical trial.
- •Life expectancy of less than 12 months.
- •No health insurance.
排除标准
- 未提供
研究组 & 干预措施
Move-Up arm
lok™ suture anchors range and associated instrumentation
干预措施: Rotator cuff lesions repair combined to a long head of biceps pathology (Procedure)
Move-Up arm
lok™ suture anchors range and associated instrumentation
干预措施: PASTA lesion (Procedure)
Move-Up arm
lok™ suture anchors range and associated instrumentation
干预措施: Shoulder instability repair (Procedure)
Routine care
Anchors and Ancillairies already CE marked (control arm) and used in routine care
干预措施: Rotator cuff lesions repair combined to a long head of biceps pathology (Procedure)
Routine care
Anchors and Ancillairies already CE marked (control arm) and used in routine care
干预措施: Shoulder instability repair (Procedure)
Routine care
Anchors and Ancillairies already CE marked (control arm) and used in routine care
干预措施: PASTA lesion (Procedure)
结局指标
主要结局
Constant score
时间窗: From enrollment to the final follow up at 12 months
The functional improvement related to the implantation of these devices will be at 3 months ± 7 days, 6 months ± 15 days and 12 months ± 15 days with the primary endpoint being the Constant score.
次要结局
- Visual Analog Scale (VAS)(From enrollment to the end of follow up at 12 months)
- Adverse Events (AEs)(from enrollment to the final follow up at 12 months)
- Subjective Shoulder Value (SSV)(From enrollment to the final follow up at 12 months)