NCT03189147

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

Terminated NA Last updated 22 September 2021

What this trial tests

NA trial testing Biceps Tenodesis in SLAP Lesion in 20 participants. Terminated before completion.

Timeline

15 January 2018

Primary endpoint
29 August 2019

29 August 2019

Quick facts

Lead sponsor	University of Alberta
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	20
Start date	15 January 2018
Primary completion	29 August 2019
Estimated completion	29 August 2019
Sites	1 location across Canada

Drugs / interventions tested

• Biceps Tenodesis
• Debridement

Conditions studied

• SLAP Lesion — all drugs for SLAP Lesion →

Sponsor

University of Alberta

Who can join

35 and older, any sex, with SLAP Lesion. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.