A randomized, multi center, parallel, open label study assessing clinical and functional outcomes after treatment of Rotator Cuff Tears using Knotless PEEK Anchors with PEEK Tip & knotless PLDLA-B TCP Anchors with PEEK Tip
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 74
- 试验地点
- 5
- 主要终点
- 1.To assess overall functional outcomes in each cohort of Knotless PEEK Anchors with PEEK tip & Knotless PLDLA-B TCP Anchors with PEEK Tip
研究概览
简要总结
Arthroscopic rotator cuff repair (RCR) has evolved into oneof the most common orthopedic surgical procedures worldwide. Suture anchors areone of the most important devices in rotator cuff arthroscopic repair, theirdesign and composition continues to improve, and different surgical acts can beassociated to glean the final result. VIPLOK PEEK Knotless Screw/Wedge anchors(PEEK Tip) and VIPLOK PLDLA and B TCP Knotless Screw or wedge (PEEK Tip) areintended for soft tissue fixation to the bone. In current study we plan toevaluate and compare efficacy of both devices via change in ASES, ConstantMurley shoulder outcome scores, Penn-Shoulder Score, SANE score, SST score andquick DASH score. Duration of surgery, RCT repair failure assessment and timeto recovery will also be done as a part of efficacy assessment. Efficacy andsafety of both devices will also be compared. Clinical data collected throughthis study will be of great benefit to the research field and potentially willbe beneficial to the society.
研究设计
- 研究类型
- Interventional
- 分配方式
- Stratified block randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 30.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Male/ female participants between ≥30 years and ≤ 70 of age at the time of consent 2.Participants with Rotator Cuff Tears requiring primary RCT repair 3.Participants/ Legally Acceptable Representative who are willing to provide written Informed Consent and comply with study procedures.
排除标准
- •1.Participants with evidence of osteoarthritis in the shoulder 2.Participants with evidence of infection, tumor or necrosis in the shoulder 3.Participants who had undergone previous surgery of the same shoulder 4.Participants having any contraindications for undergoing MRI 5.Participants with ˃ 9% HbA1c (Clinical laboratory reports up to 3 months will be considered valid otherwise participants will undergo blood investigation for HbA1C) 6.Participants with a history of deep vein thrombosis (DVT) 7.Participants who are smokers (smoking ˃ 20 cigarettes/day) 8.Participants with sensitivity to PEEK/ PLDLA-BTCP material 9.Participants with any condition which makes the subject unsuitable for study participation which as per the investigator would jeopardize the outcome of the trial or participant who, in the judgment of the investigator, will be unlikely to comply with the requirements of this protocol.
- •10.Pregnant and lactating female at the time of screening.
结局指标
主要结局
1.To assess overall functional outcomes in each cohort of Knotless PEEK Anchors with PEEK tip & Knotless PLDLA-B TCP Anchors with PEEK Tip
时间窗: Time frame Screening/ Baseline, month 3, month 6, month 12, month 18 and month 24
次要结局
- 1.To assess the patient reported outcomes in each cohort of Knotless PEEK Anchors with PEEK tip & Knotless PLDLA-BTCP Anchors with PEEK Tip during RCT repair.(2.To assess the failure rate in each cohort of Knotless PEEK Anchors with PEEK tip & Knotless PLDLA-BTCP Anchors with PEEK Tip during RCT repair.)