Treatment of the Biceps With Concomitant Supraspinatus Tears

Supraspinatus Tear Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05660031
• Other study ID #: 2021-00066
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2021
• Est. completion date: June 1, 2025

Study information

• Verified date: March 2024
• Source: La Tour Hospital
• Contact: Alexandre Lädermann, MD
• Phone: +41 22 71 975 55
• Email: alexandre.laedermann[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: June 1, 2025
• Est. primary completion date: June 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Supraspinatus Tear

Intervention

Procedure:
• LHB Tenotomy
Will be performed arthroscopically by cutting the LHB at its origin with arthroscopic scissors
• LHB Tenodesis
"ill be performed arthroscopically with a tenodesis at the top of the articular margin using an onlay technique.

Locations

Country	Name	City	State
Canada	Group 23 Sports Medicine	Calgary	Alberta
Switzerland	la Tour hospital	Meyrin	Geneva
United States	Sports Medicine and Shoulder Surgery, University of Michigan	Ann Arbor	Michigan
United States	Oregon Health & Science University	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
La Tour Hospital

Countries where clinical trial is conducted

United States,  Canada,  Switzerland, 

Outcome

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