Arthroscopic Rotator Cuff Repair Augmented with Bioinductive Implant for Full-Thickness Tears: a Randomized Controlled Study
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- Rotator cuff repair integrity
研究概览
简要总结
The purpose of this randomized-controlled study is to compare outcomes of arthroscopic rotator cuff repair augmented with a Bioinductive Implant (study group) to standard arthroscopic rotator cuff repair (control group). The primary outcome of this study is rotator cuff repair integrity (absence of full- or partial-thickness defect) demonstrated on ultrasound at 1-year postoperatively. The investigators hypothesize that the study group will have higher rates of repair integrity demonstrated on ultrasound at 1-year postoperatively.
详细描述
A bioinductive patch is an implant that may foster tendon regrowth and healing following surgery. Patients will be randomized into one of two groups: control and investigational. All surgical patients will have failed non-surgical/conservative options for 6 weeks. Patients in the "control group" will receive the standard surgery (arthroscopic rotator cuff repair) . Patients in the "experimental group" will receive the same surgical treatment, with the addition of the bioinductive patch. This patch will be implanted during surgery. Then, using a combination of ultrasound studies and other measures, the investigators will assess how well the patch works compared to surgery alone.
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)
盲法说明
The study participant will not have knowledge of which treatment group he/she is randomized into for the duration of the study. Because the care provider/investigator will be required to implant the bioinductive patch, the physician will know into which treatment group each patient falls.
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
- •Indicated and scheduled for arthroscopic rotator cuff repair.
- •Full-thickness medium (1-3 cm), large (3-5 cm), and massive (>5 cm) rotator cuff tears involving the supraspinatus and/or infraspinatus tendons demonstrated on magnetic resonance or ultrasound imaging.
- •Chronic, degenerative rotator cuff tears.
- •Ability to read and understand English.
- •Age ≥18 years
- •Patient failed ≥6 weeks of conservative treatment, which included structured, in-person physical therapy or documented home therapy
排除标准
- •Patient scheduled for open or mini-open rotator cuff repair
- •Prior surgery of affected shoulder (except diagnostic arthroscopy)
- •Partial-thickness rotator cuff tears
- •Small (<1 cm) rotator cuff tears
- •Rotator cuff tears involving the subscapularis tendon
- •Acute and traumatic rotator cuff tears
- •Active infection
- •Autoimmune and rheumatologic disorders, including rheumatoid arthritis, psoriatic arthritis, systemic lupus erythematosus
研究组 & 干预措施
Control Group
Surgical treatment alone, consisting of arthroscopic rotator cuff repair. Ultrasound postoperatively at 1 year.
干预措施: arthroscopic rotator cuff repair (Procedure)
Control Group
Surgical treatment alone, consisting of arthroscopic rotator cuff repair. Ultrasound postoperatively at 1 year.
干预措施: Ultrasound Imaging (Diagnostic Test)
Study Group
Identical surgical treatment as control group plus bio-inductive patch implant. Ultrasound postoperatively at 1 year.
干预措施: arthroscopic rotator cuff repair (Procedure)
Study Group
Identical surgical treatment as control group plus bio-inductive patch implant. Ultrasound postoperatively at 1 year.
干预措施: Bioinductive implant (Biological)
Study Group
Identical surgical treatment as control group plus bio-inductive patch implant. Ultrasound postoperatively at 1 year.
干预措施: Ultrasound Imaging (Diagnostic Test)
结局指标
主要结局
Rotator cuff repair integrity
时间窗: Preoperative to 1 year postoperative
absence of full- or partial-thickness defect as demonstrated on ultrasound at 1-year postoperatively.
次要结局
- PROMs scores for upper extremity function(Preoperative to 2 years postoperative)
- PROMs scores for upper extremity pain interference(Preoperative to 2 years postoperative)
- Shoulder Range of Motion(Preoperative to 2 years postoperative)
- Reoperation(2 years postoperative)
- PROMs scores for depression(Preoperative to 2 years postoperative)
- Shoulder Strength(Preoperative to 2 years postoperative)
- Complications(Intraoperative to 2 years postoperative)
研究者
Stephanie Muh, MD
Deputy Service Chief, Principal Investigator
Henry Ford Health System