跳至主要内容
临床试验/NCT05564494
NCT05564494招募中不适用

The Arthroscopic Treatment of Anterior Shoulder Instability (ATRASI): A Pilot Multicentre Randomized Controlled Trial

Nova Scotia Health Authority3 个研究点 分布在 2 个国家目标入组 200 人开始时间: 2023年4月25日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
200
试验地点
3
主要终点
Participant Adherence

研究概览

简要总结

This is a pilot multi-centre, double blinded randomized controlled trial. The primary outcome of this pilot trial will be feasibility. Prior to conducting a large definitive trial, the investigators will conduct this pilot trial comparing arthroscopic Bankart repair with arthroscopic anatomic glenoid reconstruction (AAGR), evaluating recurrent dislocation rates and functional outcomes over a 24-month period. The feasibility objectives are: (1) to evaluate the investigators ability to recruit patients across multiple sites and (2) to assess study protocol adherence and ability to follow patients to 24 months. Clinical objectives for the pilot trial are exploratory only. The investigators wish to gather means and standard deviations for clinical outcomes to power their future definitive trial. The objectives of the definitive trial will include a comparison of patient-reported outcomes at the two-year post-operative time point, differences in recurrence rates, complication rates, functional shoulder assessments, and return to work/sport.

详细描述

The glenohumeral joint has the greatest range of motion of any major articulation in the human body. This increased mobility leaves the joint vulnerable to dislocation and the development of instability and osteoarthritis, both of which can have drastic effects on work productivity and quality of life. Symptomatic instability following anterior glenohumeral dislocation is especially common among young people. In patients under 20 years of age, recurrent dislocation rates may be as high as 90%. The high incidence of recurrent dislocation negatively affects the individual and society in general. It may limit range of movement and can require multiple hospital visits for treatment and surgical procedures to prevent further dislocations. Chronic instability of the joint may prevent the individual from participating in sports and physical activity, and from returning to work, and leads to osteoarthritis. The development of osteoarthritis in young patients is devastating and leads to changes within the shoulder that are not easily repairable and results in the need for early shoulder replacements which are costly for both the healthcare system and for the patient themselves. It has been well-established in the literature that surgical management of anterior shoulder instability provides a lower recurrence rate and better rates of return to sport than non-operative treatment. Non-operative treatment of primary anterior shoulder instability has been found to have a high rate of progression to arthritis at a long term follow-up, due to recurrence.

Recurrence rates are influenced by multiple factors including age and gender of the patient, contact sport participation, ligamentous laxity, and the bone loss both on the glenoid and humerus. Of these factors, bone loss is the only modifiable factor. Glenoid defects, present in 22% of patients with acute dislocations, are found in 73% of recurrent dislocations. The management of glenoid bone deficiency in shoulder instability has been a challenge to surgeons for many years. Anteroinferior glenoid bone loss is a significant contributor to recurrent instability through alteration of both the glenohumeral joint contact area and congruency of the articular surfaces. Previous researchers outlined the additive effect of humeral and glenoid bone loss in contributing to shoulder instability and stressed the importance of bony procedures in creating a stable shoulder, particularly for the young active patient. For patients with large anterior glenoid defects (>25%) or other risk factors for recurrence, bone grafting procedures, including autogenous coracoid transfer to the anterior glenoid (i.e. Latarjet procedure) as well as iliac crest autograft and tibial allografts (i.e. arthroscopic anatomic glenoid reconstruction (AAGR)) have been described. These procedures have all been shown to be equally effective and reliable techniques for treating shoulder instability.

The most common pathology in recurrent shoulder instability is anteroinferior capsulolabral avulsion. In 1938, Bankart described the detachment of the anterior inferior labrum from the glenoid rim as a cause of anterior instability and presented his case report of 27 patients treated surgically. In recent years, technical advancements in arthroscopic shoulder surgery have radically altered the treatment of anterior shoulder instability. Arthroscopic techniques have been developed in an attempt to reduce common challenges of open repair including wide dissection, loss of external rotation and post-operative pain. Arthroscopic labral repair, now considered routine and reliable, is the treatment of choice for many cases of recurrent anterior shoulder instability in North America.

Although the results of arthroscopic anterior labral repair using current techniques have been shown to parallel results of open anterior stabilizations in most patients, it is recognized that arthroscopic labral repair is less effective in patients with risk factors for failure such as young age, hyperlaxity, competitive contact sport participation, and in particular glenoid or humeral bone loss. A recently published long-term study on patient outcomes following isolated arthroscopic Bankart repair found a high rate of recurrence and development of arthritis at a 9-12- year follow-up. The authors state that an isolated Bankart repair does not solve the issue of glenoid bone loss.

While bony procedures have traditionally been reserved for cases with bone loss of the glenoid or humerus (so-called Hill-Sachs lesions), there are some regions in which surgeons prefer this type of procedure regardless of the degree of bone loss. This is in part due to recent findings revealing that bone loss may be underestimated by current methods of preoperative measurement. Currently, there are three common methods used to assess bone loss. Preoperative CT and MRI are employed to quantify bone defects, and arthroscopic evaluation may also be used.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
16 Years 至 40 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Recurrent anterior glenohumeral dislocation (two or more incidents)
  • Presence of glenoid and/or humerus bone loss on imaging (x Ray, CT or MRI)

排除标准

  • Uncontrolled diabetes (Hgb A1C >7%)
  • Prior surgery of affected shoulder
  • Pregnancy
  • Multidirectional instability
  • Posterior instability
  • Paralysis of the shoulder
  • Severe systemic illness
  • Presence of massive rotator cuff tear
  • Patients that present with < 10% or > 25% bone loss under preoperative imaging.
  • Generalized laxity (>5/9 Beighton Score)

研究组 & 干预措施

Bankart Repair

Active Comparator

Arthroscopic Bankart repair procedures will be performed according to each individual surgeon's usual technique. Procedures will be performed with the patient in the lateral or beach-chair position. Repairs for associated or conjoined superior labral anterior-to-posterior (SLAP) tears will be documented and performed at the surgeon's discretion. Labral detachments will be repaired with the use of suture-anchor fixation and arthroscopic tying techniques. Either two or three suture anchors will be used. Capsular redundancy will be addressed with arthroscopic suture plication at the surgeon's discretion. Surgeons will mobilize the capsulolabral tissue as deemed necessary. Surgical time and video of the operation will be recorded, and photographs will be taken documenting any bone loss.

干预措施: Bankart Repair (Procedure)

Anatomic Glenoid Reconstruction

Experimental

The surgical technique was the lateral decubitus all-arthroscopic anatomic glenoid reconstruction procedure for treatment of anterior shoulder instability as described by Wong et al. (2015). The procedure is done in a semi-lateral decubitus position that assists with optimal graft placement on the native glenoid. The investigators utilize the cannulated Bristow-Latarjet Instability Shoulder System (Depuy-Mitek, MA, USA). The surgical technique is identical to that of arthroscopic Bankart repair with one additional step. Prior to insertion of anchors, one additional medal portal is created for insertion of the bone graft. The distal tibia allograft is prepared; the cannulated guide is attached and advanced through the rotator interval and secured with two cannulated screws. Finally, the Bankart repair is performed above the graft. Surgical time and video of the operation will be recorded, and photographs will be taken documenting any bone loss.

干预措施: Anatomic Glenoid Reconstruction (Procedure)

结局指标

主要结局

Participant Adherence

时间窗: Measured throughout the entire study, up to 2 years

Protocol adherence

Patient Follow-up

时间窗: Measured throughout the entire study, up to 2 years

Proportion of Patients Followed at 24 months

Subject Recruitment

时间窗: Measured throughout the entire study, up to 2 years

Recruitment of 100 participants

次要结局

  • Disabilities of the Arm, Shoulder, and Hand (DASH)(Measured at 6 month, 1 year, and 2 year time points)
  • Range of Motion(Measured at 6 month, 1 year, and 2 year time points)
  • Quality of Life Assessment (EQ-5D-5L)(Measured at 6 month, 1 year, and 2 year time points)
  • Strength(Measured at 6 month, 1 year, and 2 year time points)
  • Radiographic Imaging(Measured with at least one CT and one x-ray at any time point prior to surgery and once post surgery up to a year after the surgery. The post surgical time frames for this imaging may differ depending on booking, availability, and wait times)
  • American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form(Measured at 6 month, 1 year, and 2 year time points)
  • MARX Physical Activity Questionnaire(Measured at 6 month, 1 year, and 2 year time points)
  • Incidence of Recurrence(Measured at 6 month, 1 year, and 2 year time points)
  • The Western Ontario Shoulder Instability Index (WOSI)(Measured at 6 month, 1 year, and 2 year time points)

研究者

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

Ivan Wong, MD

Principal Investigator

Nova Scotia Health Authority

研究点 (3)

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