跳至主要内容
临床试验/NCT01405781
NCT01405781已完成不适用

Functional and Radiographic Outcomes After Shoulder Surgery

University of Utah2 个研究点 分布在 1 个国家目标入组 1,034 人开始时间: 2011年5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
1,034
试验地点
2
主要终点
To determine the outcomes after several different shoulder surgical procedures for varying shoulder problems.

研究概览

简要总结

The objective of this study is twofold: First, to determine whether higher levels of pre-operative psychological distress predict worse outcomes after arthroscopic rotator cuff repair; second, to obtain functional outcomes (VAS pain, VAS satisfaction, VAS function, Simple Shoulder Test (SST) and American Shoulder and Elbow Surgeons (ASES) Score), physically examine and perform a radiographic analysis of patients at a minimum of 6 months after reverse total shoulder arthroplasty, total shoulder arthroplasty, arthroscopic scapulothoracic bursectomy, acromioclavicular joint reconstruction and arthroscopic rotator cuff repair.

详细描述

Clinical outcome studies have been performed in the evaluation of a variety of shoulder pathologies after surgical treatment. Among these disease processes include glenohumeral osteoarthritis, rotator cuff arthropathy, acromioclavicular separations and scapulothoracic bursitis. A variety of outcomes studies have been performed on these pathologies although few have utilized several functional outcome measures. Also with respect to each of these diagnoses, several specific areas of research regarding outcomes assessment have not been investigated.

Glenohumeral osteoarthritis is one of the most common shoulder pathologies treated by orthopedic surgeons. For endstage osteoarthritis, an anatomic total shoulder arthroplasty provides excellent pain relief and functional improvement. In order to perform the replacement, the rotator cuff tendon in the front of the shoulder (subscapularis) needs to be taken down and then repaired at the completion of the case. There are three basic methods of takedown and repair: tenotomy, peel-off and lesser tuberosity osteotomy. The osteotomy has been compared clinically to tenotomy and found to provide a lower rate of subscapularis tears, higher outcome scores and universal healing evaluated using ultrasound and the PENN shoulder score.1 Gerber et al has also evaluated long-term outcomes of total shoulder arthroplasty with lesser osteotomy using the Constant score as a measure of outcomes.2 Unfortunately, many outcome studies evaluating total shoulder arthroplasty utilize the Simple Shoulder Test and the American Shoulder and Elbow Surgeons (ASES) Score which have not been evaluated. Also, osteotomy was performed only utilizing a "fleck" of bone instead of the entire lesser tuberosity. No studies to date have evaluated TSA with an osteotomy of the entire lesser tuberosity.

Reverse total shoulder arthroplasty has shown be a predictable operation for the treatment of rotator cuff arthropathy with clinical improvements in both pain and function at long term. 3,4 Dislocation has been reported between 0% to 9% after reverse total shoulder arthroplasty and has been defined as one of the top three most common complications associated with reverse TSA.3-10 There is considerable debate regarding whether the subscapularis tendon needs repair after reverse TSA. Edwards et al reported a statistically significant reduction in dislocation rates from 9% to 0% with addition of subscapularis repair.10 These results had significant bias with regards to randomization of patients. Similarly, all patients in the non-repair group were at the initial portion of his learning curve. Consequently, the risk for instability is likely lower than reported in his series.

Acromioclavicular joint separations represent one of the most common shoulder injuries accounting for approximately 9% of shoulder girdle injuries.11 Acromioclavicular injuries have been classified with increasing severity from I to VI based upon disruption of the various ligamentous and muscular supports including the acromioclavicular ligaments, coracoclavicular ligaments and deltotrapezial fascia.12 Recommended initial treatment for grade I to III injuries has been nonoperative with reasonable clinical results while initial surgical stabilization has been recommended for higher grade injuries.12-15

A variety of surgical stabilization techniques for acromioclavicular joint separations have been reported including the transfer of the coracoacromial ligament from the acromion to the end of the resected distal clavicle originally described by Weaver and Dunn in 1972.16 A modification of the Weaver-Dunn acromioclavicular reconstruction was subsequently described which included coracoclavicular stabilization with nonabsorbable suture.17 Despite this modification, residual subluxation or dislocation of the acromioclavicular joint has been identified in up to 29% of patients.17 Consequently, alternative constructs have been described including an anatomic reconstruction utilizing a tendon graft which has been shown to have superior biomechanical strength compared to a Weaver-Dunn reconstruction.18

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Other

入排标准

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

入选标准

  • Patients whose primary presenting complaint of shoulder pain and who then undergo arthroscopic rotator cuff repair performed by the principal investigator for full thickness rotator cuff tear will be eligible for inclusion. All patients who have undergone reverse total shoulder arthroplasty, total shoulder arthroplasty utilizing a lesser tuberosity osteotomy, acromioclavicular joint reconstruction, arthroscopic scapulothoracic bursectomy or arthroscopic rotator cuff repair by the PI (RZT) will also be eligible for inclusion in the study. These will include patients both at the University of Utah as well as the Veteran's Administration Hospital in Salt Lake City. All patients presenting complain of shoulder pain will be given the DRAM survey preoperative and then evaluated a minimum of 6 months postoperative.

排除标准

  • All patients who have undergone total shoulder arthroplasty not utilizing a lesser tuberosity osteotomy or who have prior failed rotator cuff repair in the affected shoulder will be excluded.
  • All patients who have undergone an open repair of the supraspinatus or infraspinatus rotator cuff tendons will not be eligible.

结局指标

主要结局

To determine the outcomes after several different shoulder surgical procedures for varying shoulder problems.

时间窗: From 6 months

次要结局

  • To determine whether higher levels of pre-operative psychological distress predict worse outcomes after arthroscopic rotator cuff repair(from 6 months)

研究者

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

Robert Tashjian

M.D.

University of Utah

研究点 (2)

Loading locations...

相似试验