跳至主要内容
临床试验/NCT02759458
NCT02759458已完成不适用

Evaluation of the Healicoil Suture Anchor for Rotator Cuff Repair

Rush University Medical Center0 个研究点目标入组 40 人开始时间: 2013年11月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
40
主要终点
American Shoulder and Elbow Surgeons( ASES)-Shoulder Form

研究概览

简要总结

The purpose of the proposed study is to evaluate a new anchor for rotator cuff repair, the Smith & Nephew Healicoil anchor. This anchor utilizes a small open-construct design to promote bone-in growth and potentially allow for the release of bone marrow factors into the repair site. In vivo ovine studies comparing the Arthrex BioComposite Corkscrew FT rotator cuff anchor to the Arthrex SwivelLock anchor have shown superior bone in-growth.

Thus, this study consists of three separate aims in order to clinically and biochemically investigate the capabilities of the Healicoil anchor and its efficacy in rotator cuff repair. One, evaluate the bone in growth of the anchor compared to a standard poly-ether ether ketone (PEEK) anchor. Two, analyze the marrow elements that are released into the repair site through the open construct. Three, compare the functional outcomes of patients with rotator cuff repairs using the Healicoil anchor compared to a traditional Twinfix PEEK anchor.

详细描述

A great deal of research has been devoted to determining optimal techniques for rotator cuff repair, a common orthopedic procedure. Current repair techniques involve the use of suture anchors or transosseous tunnels, with the goal of reattaching the torn tendon to the anatomic insertion of the rotator cuff. There are a multitude of different repair constructs and anchor designs available. For example, some surgeons utilize a single row of suture anchors for repair, whereas others will use two rows of anchors in a "double row" construct. A variety of anchors are also available; some are loaded with suture and require knot tying, and others can be used in a "knotless" technique. Regardless, time zero stability of the rotator cuff repair is essential, but ideal anchor or construct has yet to be determined.

Time zero stability immediately after the rotator cuff repair is important, however, contemporary research has also focused on the cascade that influences biologic healing of these rotator cuff repairs and if augmentation can improve functional results. Specifically, various authors have looked at the cytokines, growth factors and stem cells involved in the process. The question remains of what role these factors play and whether there are techniques that can facilitate their use and improve healing of rotator cuff repairs. Data exists in a animal models that does show that some of these growth factors can improve tendon healing.

Research Plan:

The proposed study will be a prospective randomized trial of 40 patients undergoing arthroscopic repair of full thickness rotator cuff tears. Patients will be randomized to one of two groups; the Healicoil anchor vs standard 5.5 PEEK anchor. Follow-up will take place at 6 weeks, 6 months, and 1 year after rotator cuff repair.

At the time of the operative procedure bone marrow aspirate from the drill hole used for the anchors will be sent for analysis. At the 6 month mark patients will get a computer tomography (CT) scan in order to determine the amount of ingrowth within the anchor. Finally, the outcome scores within the first year will be recorded. This data will result in the publication of three separate studies.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patient is determined to have a full thickness rotator cuff tear either on pre-operative MRI scan and confirmed arthroscopically to be 1-3 cm
  • Patient elects for surgical rotator cuff repair
  • Written informed consent is obtained

排除标准

  • Revision surgery
  • Irreparable rotator cuff tear
  • Workers Compensation

结局指标

主要结局

American Shoulder and Elbow Surgeons( ASES)-Shoulder Form

时间窗: 12-month

This is a survey that assess the subject's current functionality and ability to complete daily tasks. The ASES score can be viewed as a single 100-point scale that evaluates two dimensions of shoulder function: pain and performance in activities of daily living. Each of the two domains make up for 50 of the 100 points. The higher the number on the scale, the better the pain level and subject's current functionality and ability to complete daily tasks; 100 means no shoulder pain and perfect functionality and ability to complete daily tasks.

Single Assessment Numeric Evaluation (SANE) Form

时间窗: 12-month

This is a single question survey that asks how the patient's shoulder is feeling. The Single Assessment Numeric Evaluation (SANE) is a patient rating from 0-100. Patients rate their current illness score in relation to their pre-injury baseline. The higher the number on the scale, the better the patient's shoulder is feeling compared to their pre-injury baseline. 100 means the patient's shoulder feels in perfect health compared with pre-injury baseline.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Carla Edwards

Clinical Research Manger

Rush University Medical Center

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