Clinical trial NCT02107547: Outcomes of Biceps Tenodesis or Labral Repair for Treatment of Type 2 Superior Labrum Anterior and Posterior Lesions
Official title: Evaluation of Biceps Tenodesis vs Labral Repair for Type 2 Superior Labrum Anterior and Posterior Lesions, A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 SLAP Lesions
Keywords: Randomized Controlled Trial (RCT)
Type 2 SLAP lesions
labral tear
biceps tenodesis
shoulder surgery
RCT
Comparison between two alternative surgical procedures
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2014-04-08
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to determine which of the two alternative surgical interventions (biceps tenodesis or labrum repair surgery) is better in the treatment of Type 2 Superior Labrum Anterior and Posterior lesions.

Detailed description: The labrum is a structure which provides stability to the shoulder joint. A superior labral tear from anterior to posterior lesion is an injury to the labrum at the insertion of the biceps muscle. The grading system is related to the severity of the tear. A type 2 tear is an intermediate grade tear. These are commonly treated in two ways: either by repairing the labrum with bone anchors or by cutting the biceps tendon and re-affixing it more distally. No method has been shown to be superior to the other and surgeons generally choose to proceed however they are most comfortable. The study will seek to determine how these injuries are best treated. Inclusion criteria: patients with type 2 superior labral tear from anterior to posterior tears who are under the age of 45. Throwing athletes are excluded due to their unique demands.

Subjects will be randomly assigned to one of two groups. Prior to surgery patients will be evaluated in clinic, full histories and physicals will be performed and their functional status will be evaluated using validated questionnaires including the American Shoulder and Elbow Society score and quality of life measurements.

Both groups will be treated first with a shoulder arthroscopy. The experimental portion of the study will involve whether the patient is then treated with repair of the Superior Labrum Anterior and Posterior lesion or with tenodesis. Repair of a Superior Labrum Anterior and Posterior lesion involves placing small anchors in the glenoid to re-attach the torn labrum. A biceps tenodesis involves cutting the tendon within the shoulder joint and reattached further down the arm. Physical therapy will be initiated after surgery and will be identical in both groups. It will be recommended but not required as part of the study. Progress notes, operative reports, and questionnaires will also be retained as part of the study. Patients will be in a sling for the first 4 weeks after surgery. Post-operatively, physical examinations findings and American Shoulder and Elbow Surgeons scores at 3, 6, and 12 months. These will be compared to the preoperative results and to the other experimental arm of the study. Post-operative imaging will not be obtained. No computerized tomographies will be required as part of the study. No Magnetic Resonance Imagings will be required as part of the study--patients enrolled in the study will likely have had an MRI performed outside of the study period to determine if they have an isolated Superior Labrum Anterior and Posterior tear but no MRIs will be performed as part of the study. No lab reports or Physical therapy reports will be included in the study.

Eligibility criteria: Inclusion Criteria:

* patients with MRI diagnosed Superior Labrum Anterior and Posterior 2 lesion

Exclusion Criteria:

* none

Primary outcomes:
measure: American Shoulder and Elbow Surgeons (ASES) Shoulder Score
timeFrame: one year
Secondary outcomes:
measure: EuroQol five dimensions
timeFrame: one year
Other outcomes:
Locations:
city: Chicago
country: United States
facility: The University of Chicago Medical Center
state: Illinois
Study officials:
affiliation: University of Chicago
name: Lewis L Shi, MD
role: PRINCIPAL_INVESTIGATOR
References: