Clinical Outcomes After Arthroscopic Tenotomy or Tenodesis of the Long Head of the Biceps

NCT ID: NCT02811757

Last Updated: 2016-06-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-12-31

Brief Summary

Degenerative changes of the long head of the biceps brachii (LHB) are frequent and often associated with cuff tendinopathy. The function of the LHB in the shoulder is still controversial and uncertain, whereas its function in the elbow is certain. The biceps brachii is a flexor of the elbow and supinator of the forearm. Suppression of the pathologic long head of the biceps permits pain relief and is very reliable in the literature. Two options are available for the remaining tendon : simple tenotomy or tenodesis which consists to reattach the tendon to the humerus. Our hypothesis is that there is no difference in strength or endurance of the biceps brachii after tenotomy or tenodesis of the LHB. The aim of this study was to compare the strength and the endurance of the biceps brachii during supination and flexion after tenotomy or tenodesis of the LHB.

the investigators proposed a prospective and randomized study. All the patients treated in our department for an arthroscopic rotator cuff repair were included in this study after signed consent. Participants will complete isokinetic strength and endurance testing for elbow flexion and supination on the operative and nonoperative sides a minimum of 1 year after biceps tenotomy or tenodesis. The clinical evaluation included the range of motion measurement, Constant Score, Quick-DASH and SSV at 6 weeks, 3 months, 6 months and one year.

Conditions

Arthroscopic Rotator Cuff

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

tenodesis

Group Type: EXPERIMENTAL

tenodesis

Intervention Type: PROCEDURE

tenotomy

Group Type: ACTIVE_COMPARATOR

tenotomy

Intervention Type: PROCEDURE

Interventions

tenotomy

Intervention Type: PROCEDURE

tenodesis

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• surgery tenotomy or tenodesis type of the long head of the biceps (broken tendinopathy or not rotator cuff escaping a well conducted medical treatment and under a repair or cap pathology of the long head of the biceps during the arthroscopy)
• Patients treated in the orthopedic service of the Reims University Hospital
• Patients agreeing to participate in the research and who signed the informed consent
• Major patients.

Exclusion Criteria

• prior Shoulder Surgery
• surgery scheduled contralateral shoulder
• patient protected by law

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CHU de Reims

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Chu Reims

France, Reims, France

Site Status: RECRUITING

Countries

France

Central Contacts

Xavier Ohl

Role: CONTACT

xohl@chu-reims.fr

326783272 ext. 33

Facility Contacts

Damien JOLLY

Role: primary

djolly@chu-reims.fr

326788472 ext. 33

Other Identifiers

PA13049

Identifier Type: -

Identifier Source: org_study_id