LHB Tenotomy
ProcedureWill be performed arthroscopically by cutting the LHB at its origin with arthroscopic scissors
NCT Number: NCT05660031
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.
Interested in participating?
Request Info50 year–80 year
All sexes
Interventional
Not applicable
Group 23 Sports Medicine, Calgary, Alberta, Canada
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: At 24 post-operative months
American Shoulder and Elbow Surgeon (ASES) score. From 0 (worst) to 100 (best).
Time frame: At 24 post-operative months
Visual analog scale (VAS) pain. From 0 (best) to 10 (worst)
Time frame: At 24 post-operative months
Subjective Shoulder Value (SSV). From 0 (worst) to 100 (best).
Time frame: At 24 post-operative months
Long head of the biceps (LHB) score. From 0 (worst) to 100 (best).
Time frame: At 24 post-operative months
Anterior Forward Flexion. In degrees. Will be performed with a goniometer by an independent investigator
Time frame: At 24 post-operative months
External Rotation at the side. In degrees. Will be performed with a goniometer by an independent investigator
Time frame: At 24 post-operative months
Internal Rotation to nearest spinal level. Will be performed with a goniometer by an independent investigator
Time frame: Within 2 postoperative years
Any type of post-operative complication
Time frame: At 24 post-operative months
Yes or no
Time frame: At 6 post-operative month
Radiographic outcome evaluated using an ultrasound examination.
Time frame: At 6 post-operative month
Radiographic outcome evaluated using an ultrasound examination.
Time frame: At 6 post-operative month
Radiographic outcome evaluated using an ultrasound examination.
Time frame: At 6 post-operative month
Radiographic outcome evaluated using an ultrasound examination.
Time frame: At 6 post-operative month
Radiographic outcome evaluated using an ultrasound examination.
Time frame: At 6 post-operative month
Radiographic outcome evaluated using an ultrasound examination.
Time frame: At 6 post-operative month
Radiographic outcome evaluated using an ultrasound examination.
Time frame: At 6 post-operative month
Radiographic outcome evaluated using an ultrasound examination.
Contact information is provided by the study sponsor or research team.
La Tour Hospital
Other
Treatment of the Biceps With Concomitant Supraspinatus Tears: A Multicenter Pragmatic Three-Arm Parallel-Group Randomized Surgical Trial
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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