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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02811757
Recruitment Status : Unknown
Verified June 2016 by CHU de Reims.
Recruitment status was:  Recruiting
First Posted : June 23, 2016
Last Update Posted : June 24, 2016
Sponsor:
Information provided by (Responsible Party):
CHU de Reims

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.


Condition or disease Intervention/treatment Phase
Arthroscopic Rotator Cuff Procedure: tenotomy Procedure: tenodesis Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Outcomes After Arthroscopic Tenotomy or Tenodesis of the Long Head of the Biceps
Study Start Date : December 2013
Estimated Primary Completion Date : December 2019

Arm Intervention/treatment
Experimental: tenodesis Procedure: tenodesis
Active Comparator: tenotomy Procedure: tenotomy



Primary Outcome Measures :
  1. Max Peak Torque supination [ Time Frame: 1 year ]
  2. Max peak Torque Flexion [ Time Frame: 1 year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02811757


Contacts
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Contact: Xavier Ohl 326783272 ext 33 xohl@chu-reims.fr

Locations
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France
Chu Reims Recruiting
France, Reims, France, 51092
Contact: Damien JOLLY    326788472 ext 33    djolly@chu-reims.fr   
Sponsors and Collaborators
CHU de Reims
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Responsible Party: CHU de Reims
ClinicalTrials.gov Identifier: NCT02811757    
Other Study ID Numbers: PA13049
First Posted: June 23, 2016    Key Record Dates
Last Update Posted: June 24, 2016
Last Verified: June 2016