TransfEr of the Lower Trapezius Tendon Versus Partial Cuff Repair Trial - TENET Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Feasibility of Recruitment and Follow-Up
研究概览
简要总结
Very large tears of the shoulder tendons (the 'rotator cuff') that are not surgically repairable and in the absence of significant shoulder arthritis are common in older patients, and are associated with significant pain and functional limitations. Transfer of one particular tendon called the trapezius is becoming popular as a means of restoring function and improving pain in patients with massive rotator cuff tears. This tendon is appealing for transfer, as it has a similar line of pull to the infraspinatus (one of the rotator cuff tendons). There is currently no clear surgical consensus regarding the optimal treatment of patients with symptomatic massive irreparable rotator cuff tears that are appropriate candidates for joint salvage treatment, and no high level of evidence studies to guide clinical decision making have been published.
A pilot study is required prior to the development of a full-scale trial to assess its feasibility and recruitment across clinical sites, to determine protocol adherence (errors in randomization), and patient retention over a 12-month period.
The main objective of this pilot trial is to assess a composite measure of feasibility including recruitment, protocol adherence, and patient retention at one-year. The secondary objectives, currently exploratory only, are to determine the clinical outcomes of lower trapezius tendon transfer versus arthroscopic rotator cuff partial repair and biceps tenodesis/tenotomy on clinical outcome measures, shoulder function, adverse events and reoperation rates at two-years.
This pilot study is a parallel-group multicentre randomized controlled trial with participating sites across Canada, and one site in the United States.
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 (Outcomes Assessor)
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
- •Adult male and females over 18 years of age
- •MRI confirmed diagnosis of massive rotator cuff tears defined using the Schumaier 2020 definition of massive cuff tears which includes the following criteria:
- •Retraction of the tendons to the glenoid rim, measured in either the coronal or axial plane
- •Greater than or equal to 67% of the greater tuberosity exposed in the axial plane
- •Diagnosed either with MRI or intra-operatively ** Note: patients may be screened for inclusion using ultrasound, and the Cofield or Gerber definitions of massive cuff tear defined as either 5cm or greater in maximum length or 2 more tendon involvement respectively, however their must meet the Schumaier et al 2020 definition for final inclusion.
- •Features of irreparability of their rotator cuff tendon tear including:
- •Tendon retraction equal to or greater than 3cm16
- •Remnant tendon length of supraspinatus <15mm (as measured on coronal sequence of shoulder MRI)62
- •Goutallier grade 3 or 4 fatty infiltration of the supraspinatus
- •An external rotation lag present on clinical exam. A positive external rotation lag will be considered as inability to perform external rotation with or against gravity.
- •Provision of informed consent
排除标准
- •Patients with complete subscapularis tears
- •Patients with concomitant injuries of the affected shoulder
- •Previous surgery on the affected shoulder
- •Hamada grade 3 or above changes on plain films of the shoulder
- •Substantial shoulder comorbidity (e.g. Bankart lesion or osteoarthritis [defined as joint space narrowing or osteophytes present on radiographs and confirmed at the time of arthroscopy])
- •Substantial medical comorbidity that could impact the effectiveness of surgical intervention
- •Inability to speak English or French
- •Patients that will likely have difficulty with maintaining follow-up in the opinion of the evaluators (no fixed address, unwilling to be followed, incarcerated individuals, etc.)
- •Cases involving litigation or workplace insurance claims
研究组 & 干预措施
Lower Trapezius Tendon Transfer
The Lower Trapezius Tendon Transfer procedure involves transferring one of the other tendons located just outside the shoulder (the 'lower trapezius') and attaching this to the upper part of the arm bone, in the place of the torn rotator cuff tendon.
干预措施: Lower Trapezius Tendon Transfer (Procedure)
Partial Rotator Cuff Repair
The rotator cuff repair procedure involves reattaching the torn tendon(s) back to the upper part of the arm bone.
干预措施: Partial Rotator Cuff Repair (Procedure)
结局指标
主要结局
Feasibility of Recruitment and Follow-Up
时间窗: 1-year
Assess the feasibility of this pilot trial as determined by: (1) Recruitment rate of 6 per month across study centres; (2) 3 or fewer crossovers for enrolled participants; and (3) 85% of participants have a full adherence to protocol.
次要结局
- The Western Ontario Rotator Cuff Score (WORC)(2-years post-operative)
- Constant Score(2-years post-operative)
- American Shoulder and Elbow Surgeons Standardized Shoulder Assessment form (ASES)(2-years post-operative)
- Subjective Shoulder Value(2-years post-operative)
- EuroQol EQ-5D-5L(2-years post-operative)
- Functional Range of Motion(2-years post-operative)
- Strength(2-years post-operative)
- Ultrasound(1-year post-operative)
- Reoperation Rate(2-years post-operative)