An interventional study of LHB Tenotomy and LHB Tenodesis in Supraspinatus Tear, sponsored by La Tour Hospital. Recruiting at 4 sites in 3 countries. Open to participants aged 50 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-04-25.
Sponsored by La Tour Hospital · Not applicable, Interventional, and Treatment
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 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.
La Tour Hospital is the lead sponsor of 14 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
The long head of the biceps (LHB) will be left intact.
The long head of the biceps (LHB) will be cut at its origin.
Procedure: LHB Tenotomy
The long head of the biceps (LHB) will be cut at its origin and reattached.
Procedure: LHB Tenodesis
Will be performed arthroscopically by cutting the LHB at its origin with arthroscopic scissors
"ill be performed arthroscopically with a tenodesis at the top of the articular margin using an onlay technique.
ASES score
American Shoulder and Elbow Surgeon (ASES) score. From 0 (worst) to 100 (best).
Time frame: At 24 post-operative months
VAS pain
Visual analog scale (VAS) pain. From 0 (best) to 10 (worst)
Time frame: At 24 post-operative months
SSV
Subjective Shoulder Value (SSV). From 0 (worst) to 100 (best).
Time frame: At 24 post-operative months
LHB score
Long head of the biceps (LHB) score. From 0 (worst) to 100 (best).
Time frame: At 24 post-operative months
AFF
Anterior Forward Flexion. In degrees. Will be performed with a goniometer by an independent investigator
Time frame: 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
Time frame: At 24 post-operative months
IR
Internal Rotation to nearest spinal level. Will be performed with a goniometer by an independent investigator
Time frame: At 24 post-operative months
Complications
Any type of post-operative complication
Time frame: Within 2 postoperative years
Patient satisfaction
Yes or no
Time frame: At 24 post-operative months
Location of the defect (at the foot print | medial cuff failure)
Radiographic outcome evaluated using an ultrasound examination.
Time frame: At 6 post-operative month
Status of the biceps tendon (intact | in continuity | defect)
Radiographic outcome evaluated using an ultrasound examination.
Time frame: At 6 post-operative month
Signs of anchor displacement and location (lateral | medial row).
Radiographic outcome evaluated using an ultrasound examination.
Time frame: At 6 post-operative month
Tendon thickness
Radiographic outcome evaluated using an ultrasound examination.
Time frame: At 6 post-operative month
Number of patients with bursitis
Radiographic outcome evaluated using an ultrasound examination.
Time frame: 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.
Time frame: At 6 post-operative month
Number of patients with liquid in the bicipital sheath
Radiographic outcome evaluated using an ultrasound examination.
Time frame: At 6 post-operative month
Number of patients with hypervascularization of the sheath
Radiographic outcome evaluated using an ultrasound examination.
Time frame: At 6 post-operative month
Plan to share: No
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La Tour Hospital