BicepsTenodesis vs. Biceps Debridement in Combined RC Tears and SLAP Lesions

NCT03189147 | Terminated

• 1 other identifier: Pro00072759
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The appropriate treatment of labral lesions such as SLAP tears in patients undergoing RC tears repair is controversial. Most surgeons are reluctant to repair RC and SLAP tears simultaneously due to the high likelihood of prolonged postoperative immobilization, stiffness and poor clinical outcomes. The current standard care interventions include debridement, biceps tenotomy or tenodesis rather than surgical repair of SLAP tears. Simple debridement is a low cost and time-saving procedure that has the advantage of maintaining the anatomy of the long head of biceps (LHB), a muscle that acts as an active depressor of the head of the humerus in patients with RC tears. Biceps tenotomy is also low cost and time-saving; however, since the LHB is released from its attachment in the shoulder joint, the anatomy is not preserved and results in decreased strength and possible development of a 'Popeye' deformity. Biceps tenodesis has higher costs and time than the other two approaches, but has the advantage of preserving the LHB anatomy and power, and a lower possibility of developing complications. Finally, labral repair has the highest costs and associated surgical time and may lead to increase stiffness after surgery, particularly in patients over 45 years old. Currently, the standard care of the surgeons involved in this study is to use either debridement or biceps tenodesis to address labral lesions in patients undergoing surgery for their RC tear. Based on the current evidence and current practice in our facility, we aim to compare the efficacy of tenodesis versus debridement in patients with combined RC tear, degenerative labrum (SLAP tears) and a normal biceps tendon.

Conditions

SLAP Lesion

Outcome Measures

Primary Outcomes (1)

• Change in Visual Analog Scale (VAS) in different time points

  Pain at rest, sleep and with activity will be measured using an 11-point VAS (0-10), a reliable and valid method of measuring patient-reported pain.

  Baseline, 2-weeks, 6-weeks, 3-months, 6-months and 12-months

Secondary Outcomes (1)

• Range of Motion

  Baseline, 6-weeks, 3-months, 6-months and 12-months

Other Outcomes (7)

• Shoulder Flexion Strength

  Baseline, 6-months and 12-months

• Shoulder Abduction Strength

  Baseline, 6-months and 12-months

• Shoulder External Rotation Strength

  Baseline, 6-months and 12-months

Study Arms (2)

Biceps Tenodesis

EXPERIMENTAL

Patients in this group will received biceps tenodesis intervention to address their labral lesion

Procedure: Biceps Tenodesis

Debridement

ACTIVE COMPARATOR

Patients in this group will received debridement intervention to address their labral lesion

Procedure: Debridement

Interventions

Biceps Tenodesis PROCEDURE

Surgical procedure that is usually performed for the treatment of labral lesions in patients undergoing arthroscopic rotator cuff repair

Biceps Tenodesis

Debridement PROCEDURE

Surgical procedure that is usually performed for the treatment of labral lesions in patients undergoing arthroscopic rotator cuff repair

Debridement

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults over 35 years of age presenting with a high grade partial-thickness or full-thickness RC tear associated with a degenerative SLAP tear and a normal biceps tendon, confirmed by appropriate imaging, that can be surgically repaired using an arthroscopic approach will be eligible for the study.

You may not qualify if:

• Subjects presenting with pulley involvement, high grade full-thickness RC tears (\>3cm), biceps pathology, previous surgery to the affected shoulder, history of shoulder dislocation, inflammatory disease, or moderate to severe degenerative glenohumeral arthropathy (Kellgren-Lawrence Grade 3 or 4), major shoulder joint trauma, infection, or avascular necrosis will be excluded. Furthermore, those with psychiatric illness, cognitive impairment, or health conditions that preclude informed consent, life expectancy of less than 1 year, who do not speak/read/understand English, have no fixed address or contact, or are unwilling to complete follow-ups will also be excluded

Sponsors & Collaborators

• University of Alberta: lead

Study Sites (1)

Sturgeon Community Hospital

St. Albert, Alberta, T8N 6C4, Canada

Location

MeSH Terms

Interventions

Debridement

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2017
• First Posted: June 16, 2017
• Study Start: January 15, 2018
• Primary Completion: August 29, 2019
• Study Completion: August 29, 2019
• Last Updated: September 22, 2021

Record last verified: 2021-09

Locations

CA (1)