Treatment of the Biceps With Concomitant Supraspinatus Tears

Treatment of the Biceps With Concomitant Supraspinatus Tears: A Multicenter Pragmatic Three-Arm Parallel-Group Randomized Surgical Trial

The long head of the biceps (LHB) tendon is thought to be a common source of shoulder pain and dysfunction in patients with rotator cuff pathology. Tenotomy and tenodesis have been shown to produce favourable and comparable results in treating LHB lesions, but a controversy still exists regarding the treatment of choice. Some suggest that tenotomy should be reserved for older, low-demand patients, while tenodesis should be performed in younger patients and those who engage in heavy labor. Proponents of tenotomy suggest that this is a technically easy procedure that leads to easy rehabilitation and fast return to activity with a low complication and reoperation rate. However, those who support LHB tenodesis list good preservation of elbow flexion and supination strength, improvement of functional scores, elimination of pain, and avoidance of cosmetic deformity as benefits of the procedure. Alternatively, the LHB can be maintained in the joint without tenodesis or tenotomy. In fact, it has not been clearly shown that LHB tenodesis or tenotomy leads to improved outcomes compared to leaving the biceps tendon intact.

Study Overview

• Status: Recruiting
• Conditions: Supraspinatus Tear
• Intervention / Treatment: Procedure: LHB Tenotomy; Procedure: LHB Tenodesis

Detailed Description

The long head of the biceps (LHB) tendon is thought to be a common source of shoulder pain and dysfunction in patients with rotator cuff pathology.Tenotomy and tenodesis have been shown to produce favourable and comparable results in treating LHB lesions, but a controversy still exists regarding the treatment of choice. Some suggest that tenotomy should be reserved for older, low-demand patients, while tenodesis should be performed in younger patients and those who engage in heavy labor. Proponents of tenotomy suggest that this is a technically easy procedure that leads to easy rehabilitation and fast return to activity with a low complication and reoperation rate. However, those who support LHB tenodesis list good preservation of elbow flexion and supination strength, improvement of functional scores, elimination of pain, and avoidance of cosmetic deformity as benefits of the procedure. Alternatively, the LHB can be maintained in the joint without tenodesis or tenotomy. In fact, it has not been clearly shown that LHB tenodesis or tenotomy leads to improved outcomes compared to leaving the biceps tendon intact. The primary goal of this prospective multicenter randomized study is to evaluate whether LHB tenodesis grants superior post-operative functional outcomes compared to LHB tenotomy or leaving the LHB intact in patients undergoing rotator cuff repair (RCR) for an isolated full-thickness lesion of the supraspinatus. The primary goal of this prospective multicenter randomized study is to evaluate whether LHB tenodesis grants superior post-operative functional outcomes compared to LHB tenotomy or leaving the LHB intact in patients undergoing rotator cuff repair (RCR) for an isolated full-thickness lesion of the supraspinatus. The secondary goals are to determine whether there is a difference in post-operative functional outcomes between the LHB tenotomy group and the Intact LHB group, and if there is a difference in complication rates or patient satisfaction between the three groups.

• Study Type: Interventional
• Enrollment (Estimated): 180
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alexandre Lädermann, MD; Phone Number: +41 22 71 975 55; Email: alexandre.laedermann@gmail.com

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T3B 6B7
      • Recruiting
      • Group 23 Sports Medicine
      • Contact: Ian K Lo, MD; Email: ikylo@ucalgary.ca
• Switzerland
  • Geneva
    • Meyrin, Geneva, Switzerland, 1217
      • Recruiting
      • La Tour Hospital
      • Contact: Alexandre Lädermann, MD; Phone Number: +41 22 719 75 55; Email: alexandre.laedermann@gmail.com
• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • Recruiting
      • Sports Medicine and Shoulder Surgery, University of Michigan
      • Contact: Asheesh Bedi, MD; Email: asheesh.bedi@gmail.com
  • Oregon
    • Portland, Oregon, United States, 97239
      • Recruiting
      • Oregon Health & Science University
      • Contact: Patrick Denard, MD; Email: pjdenard@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patient voluntarily consents to participate in the study and has the mental and physical ability to participate in the study, fill out subjective questionnaires, return for follow-up visits, and comply with prescribed post-operative physical therapy.
• Full thickness tear of the supraspinatus tendon
• Intact subscapularis tendon
• Primary rotator cuff repair
• Age 50-80

Exclusion Criteria:

• Previous full thickness biceps tear
• Infection and neuropathic joints
• Known or suspected non-compliance, drug or alcohol abuse
• Patients incapable of judgement or under tutelage
• Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, contraindication for MRI scan etc.
• Enrolment of the investigator, his/her family members, employees and other dependent persons
• Patient declines to participate in study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Leaving LHB Intact; The long head of the biceps (LHB) will be left intact.
Experimental: LHB tenotomy; The long head of the biceps (LHB) will be cut at its origin.	Procedure: LHB Tenotomy; Will be performed arthroscopically by cutting the LHB at its origin with arthroscopic scissors
Experimental: LHB Tenodesis; The long head of the biceps (LHB) will be cut at its origin and reattached.	Procedure: LHB Tenodesis; "ill be performed arthroscopically with a tenodesis at the top of the articular margin using an onlay technique.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ASES score	American Shoulder and Elbow Surgeon (ASES) score. From 0 (worst) to 100 (best).	At 24 post-operative months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
VAS pain	Visual analog scale (VAS) pain. From 0 (best) to 10 (worst)	At 24 post-operative months
SSV	Subjective Shoulder Value (SSV). From 0 (worst) to 100 (best).	At 24 post-operative months
LHB score	Long head of the biceps (LHB) score. From 0 (worst) to 100 (best).	At 24 post-operative months
AFF	Anterior Forward Flexion. In degrees. Will be performed with a goniometer by an independent investigator	At 24 post-operative months
ER at side	External Rotation at the side. In degrees. Will be performed with a goniometer by an independent investigator	At 24 post-operative months
IR	Internal Rotation to nearest spinal level. Will be performed with a goniometer by an independent investigator	At 24 post-operative months
Complications	Any type of post-operative complication	Within 2 postoperative years
Patient satisfaction	Yes or no	At 24 post-operative months
Location of the defect (at the foot print | medial cuff failure)	Radiographic outcome evaluated using an ultrasound examination.	At 6 post-operative month
Status of the biceps tendon (intact | in continuity | defect)	Radiographic outcome evaluated using an ultrasound examination.	At 6 post-operative month
Signs of anchor displacement and location (lateral | medial row).	Radiographic outcome evaluated using an ultrasound examination.	At 6 post-operative month
Tendon thickness	Radiographic outcome evaluated using an ultrasound examination.	At 6 post-operative month
Number of patients with bursitis	Radiographic outcome evaluated using an ultrasound examination.	At 6 post-operative month
Number of patients with healing of the Supraspinatus tear according to Sugaya classification	Radiographic outcome evaluated using an ultrasound examination.	At 6 post-operative month
Number of patients with liquid in the bicipital sheath	Radiographic outcome evaluated using an ultrasound examination.	At 6 post-operative month
Number of patients with hypervascularization of the sheath	Radiographic outcome evaluated using an ultrasound examination.	At 6 post-operative month

Collaborators and Investigators

• Sponsor: La Tour Hospital
• Investigators: Principal Investigator: Alexandre Lädermann, MD, La Tour Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2021
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: December 4, 2022
• First Submitted That Met QC Criteria: December 13, 2022
• First Posted (Actual): December 21, 2022

Study Record Updates

• Last Update Posted (Actual): March 21, 2024
• Last Update Submitted That Met QC Criteria: March 20, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: tenotomy; rotator cuff repair; Long head of the biceps; Supraspinatus tear; tenodesis
• Other Study ID Numbers: 2021-00066

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No