Clinical trial NCT05660031: Treatment of the Biceps With Concomitant Supraspinatus Tears
Official title: Treatment of the Biceps With Concomitant Supraspinatus Tears: A Multicenter Pragmatic Three-Arm Parallel-Group Randomized Surgical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Supraspinatus Tear
Keywords: Long head of the biceps
Supraspinatus tear
tenotomy
tenodesis
rotator cuff repair
Lead sponsor: La Tour Hospital
Sponsor class: OTHER
First posted: 2022-12-21
Enrollment: 180
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: ASES score
timeFrame: At 24 post-operative months
Secondary outcomes:
measure: VAS pain
timeFrame: At 24 post-operative months
measure: SSV
timeFrame: At 24 post-operative months
measure: LHB score
timeFrame: At 24 post-operative months
measure: AFF
timeFrame: At 24 post-operative months
measure: ER at side
timeFrame: At 24 post-operative months
measure: IR
timeFrame: At 24 post-operative months
measure: Complications
timeFrame: Within 2 postoperative years
measure: Patient satisfaction
timeFrame: At 24 post-operative months
measure: Location of the defect (at the foot print | medial cuff failure)
timeFrame: At 6 post-operative month
measure: Status of the biceps tendon (intact | in continuity | defect)
timeFrame: At 6 post-operative month
measure: Signs of anchor displacement and location (lateral | medial row).
timeFrame: At 6 post-operative month
measure: Tendon thickness
timeFrame: At 6 post-operative month
measure: Number of patients with bursitis
timeFrame: At 6 post-operative month
measure: Number of patients with healing of the Supraspinatus tear according to Sugaya classification
timeFrame: At 6 post-operative month
measure: Number of patients with liquid in the bicipital sheath
timeFrame: At 6 post-operative month
measure: Number of patients with hypervascularization of the sheath
timeFrame: At 6 post-operative month
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: Sports Medicine and Shoulder Surgery, University of Michigan
state: Michigan
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
city: Calgary
country: Canada
facility: Group 23 Sports Medicine
state: Alberta
city: Meyrin
country: Switzerland
facility: la Tour hospital
state: Geneva
Study officials:
affiliation: La Tour Hospital
name: Alexandre Lädermann, MD
role: PRINCIPAL_INVESTIGATOR
References: