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临床试验/NCT03585491
NCT03585491进行中(未招募)不适用

Shoulder Instability Trial Comparing Arthroscopic Stabilization Benefits Compared With Latarjet Procedure Evaluation

Moin Khan1 个研究点 分布在 1 个国家目标入组 86 人开始时间: 2019年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
86
试验地点
1
主要终点
Protocol Adherence

研究概览

简要总结

The primary objective of the pilot study is to assess the feasibility of a definitive trial to determine the effect of arthroscopic capsuloligamentous repair (Bankart + Remplissage) vs. coracoid transfer (Latarjet procedure) on recurrent dislocation rates and functional outcomes over a 24-month period.

详细描述

Background:

Shoulder is a highly mobile joint with the most directional range of movement compared to other joints in the body. Thus, the surrounding supporting structures of the shoulder joint compromise on the stability of the joint, in order to accomplish this wide range of motion.

Anterior dislocations, the most common type of shoulder dislocation, are often complicated by instability, and repeated dislocations. Shoulder instability results in pain and negatively impacts quality of life. Several long-term studies have demonstrated a relationship between the repeated dislocations and the risk of arthritis.

Surgical stabilization of the shoulder improves function and may reduce the risk of developing degenerative arthritis. Two procedures are commonly performed in patients with repeated dislocations: a bony transfer procedure (Latarjet) or a soft tissue procedure (Bankart + Remplissage). The Latarjet procedure involves transferring bone to the front of the shoulder. The Bankart + Remplissage procedure involves tightening the soft tissues at the front of the shoulder joint.

Although retrospective clinical studies have suggested a reduced recurrence rate with the Latarjet procedure, there is a higher reported complication rate and potential morbidity associated with the open procedure. Several case series from high-volume surgeons in Europe have suggested the Latarjet repair to be an acceptable and potentially favorable surgical approach for all cases of recurrent anterior shoulder dislocation, even in the primary setting and in the absence of significant glenoid cup bone loss. Retrospective analysis of soft tissue repair in comparison to open coracoid (Latarjet) procedure found at 10-year follow up, redislocation rates were 13% (36) of 271 shoulders with a Bankart repair and 1% (1) of the 93 shoulders with a Latarjet repair.

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
None

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Men and women ages 18-50 years;
  • •Diagnosis of post-traumatic recurrent anterior dislocation. This will require a minimum of 2 episodes of documented dislocations either by radiographic evidence or documented reduction of anterior shoulder dislocation as well as physical examination eliciting unwanted glenohumeral translation with reproduction of symptoms;
  • •Mild glenoid bone loss as defined on CT by standardized and reproducible best-fit circle technique (>10% but <20%);
  • •Provision of informed consent.

排除标准

  • •Patients with concomitant injuries (cuff tear);
  • •Previous shoulder surgery;
  • •Patients that will likely have problems, in the judgment of the investigators, with maintaining follow-up;
  • •Epilepsy;
  • •Patients who are or at risk of being incarcerated;
  • •Diagnosis of multidirectional instability;
  • •Cases involving litigation or workplace insurance claims (e.g. WSIB);
  • •Confirmed connective tissue disorder (Ehlers-Danlos, Marfans) or Beighton hypermobility score >
  • •Pregnancy

研究组 & 干预措施

Bankart + Remplissage Procedure

Experimental

Bankart Procedure: the participant will be placed in the lateral decubitus or beach chair position. Standard diagnostic arthroscopy will be performed. The anterior capsulolabral complex will be freed from the anterior aspect of the scapular neck. The anterior aspect of the scapular neck will be decorticated using a motorized burr. A capsuloligamentous repair will be performed with the capsule shifted from inferior to superior and repaired on the glenoid face. The number of anchors used for the repair will be left to the discretion of the surgeon. Patients will be given a sling for 4 weeks, and participation in sports will not be allowed for 6 months.

干预措施: Bankart + Remplissage Procedure (Procedure)

Latarjet Procedure

Experimental

Open or Arthroscopic coracoid transfer (Latarjet Procedure): This procedure may be performed through small incisions (minimally invasive) but may require a larger incision in some cases. It involves the transfer of a nearby bony structure (the coracoid process) to the front of the shoulder joint (glenoid). This bone will then provide support to prevent the shoulder joint from dislocating.

干预措施: Latarjet Procedure (Procedure)

结局指标

主要结局

Protocol Adherence

时间窗: 2 years

Number of errors in randomization

Follow-up

时间窗: 2 years

Proportion of participants followed at two years

Recruitment Feasibility

时间窗: 10 months

Number of patients recruited

次要结局

  • Clinical Outcome(2 years)
  • Rate of Recurrence(2 years)

研究者

发起方
Moin Khan
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Moin Khan

MD, MSc, FRCSC

McMaster University

研究点 (1)

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