Biceps Tenodesis Versus Tenotomy (BicepsTvsT)

This study is currently recruiting participants.
Verified March 2014 by Panam Clinic
Sponsor:
Information provided by (Responsible Party):
Peter MacDonald, Panam Clinic
ClinicalTrials.gov Identifier:
NCT01747902
First received: December 5, 2012
Last updated: March 5, 2014
Last verified: March 2014
  Purpose

The long head of biceps brachii tendon has been known to be a pain generator and a common cause of shoulder pain and dysfunction in patients with rotator cuff pathology. Both biceps tenotomy and tenodesis have been shown to produce comparable results, but there is no consensus to date due to a lack of level I evidence. The aim of this prospective, randomized, clinical trial is to compare subjective patient-reported outcomes and objective clinical results between biceps tenotomy and biceps tenodesis for treating lesions of the long head of the biceps brachii.


Condition Intervention
Rotator Cuff Tear
Long Head of Biceps Brachii Lesions
Procedure: Biceps Tenotomy
Procedure: Biceps Tenodesis

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Biceps Tenodesis Versus Tenotomy in the Treatment of Lesions of the Long Head of Biceps Brachii: a Randomized Controlled Trial

Further study details as provided by Panam Clinic:

Primary Outcome Measures:
  • American Should and Elbow Society (ASES) [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Operative Time [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Total operative time in tenodesis vs. tenotomy procedures

  • Incidence of Revision [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    How many of each group will return for some form of surgical revision.

  • Complications [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Surgical complications present in both tenotomy and tenodesis groups.

  • Magnetic Resonance Imaging (MRI) [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    To be obtained at one year post-operatively to assess the integrity of the tenodesis procedure, and the amount of tendon retraction in the tenotomy group.

  • Strength [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Shoulder strength

  • Range of Motion [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 112
Study Start Date: January 2013
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Biceps tenodesis
The biceps tenodesis group will have their bicep detached and then re-inserted onto the shoulder.
Procedure: Biceps Tenodesis
The biceps tenodesis group will have their bicep detached and then re-inserted onto the shoulder.
Biceps Tenotomy
The biceps tenotomy group will have their bicep treated by detaching the tendon from the shoulder.
Procedure: Biceps Tenotomy
The biceps tenotomy group will have their bicep treated by detaching the tendon from the shoulder.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 years or older
  • Must benefit from arthroscopic rotator cuff surgery and inta-operative findings must confirm a lesion of the long head of biceps tendon

Exclusion Criteria:

  • Any significant comorbidities including previous surgery on affected shoulder
  • Active worker's compensation claims
  • Active joint or systemic infection, significant muscle paralysis, Charcot's arthropathy
  • Significant medical comorbidity that could alter the effectiveness of the surgical intervention (e.g., Cervical radiculopathy, polymyalgia rheumatica)
  • Major medical illness (life expectancy less then one year or unacceptably high operative risk)
  • Inability to speak or read English/French
  • Psychiatric illness that precludes informed consent
  • Unwillingness to be followed for 2 years.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01747902

Contacts
Contact: Jeff Leiter, MSc, PhD 204.927.2665 jleiter@panamclinic.com
Contact: Alexandra Legary, BSc 204.925.1558 alegary@panamclinic.com

Locations
Canada, Manitoba
Pan Am Clinic Recruiting
Winnipeg, Manitoba, Canada, R3M 3E4
Contact: Jeff Leiter, MSc, PhD    204.927.2665    jleiter@panamclinic.com   
Contact: Alexandra Legary, BSc    204.925.1558    alegary@panamclinic.com   
Principal Investigator: Peter MacDonald, MD FRCSC         
Sub-Investigator: Jeff Leiter, MSc, PhD         
Sub-Investigator: Randy Mascarenhas, MD         
Sub-Investigator: Greg Stranges, MD, FRCSC         
Sub-Investigator: Jason Old, MD, FRCSC         
Sub-Investigator: Jamie Dubberley, MD, FRCSC         
Sponsors and Collaborators
Panam Clinic
Investigators
Principal Investigator: Peter MacDonald, MD FRCSC Pan Am Clinic
  More Information

Publications:

Responsible Party: Peter MacDonald, Department Head, Orthopaedics, Panam Clinic
ClinicalTrials.gov Identifier: NCT01747902     History of Changes
Other Study ID Numbers: B2012:113
Study First Received: December 5, 2012
Last Updated: March 5, 2014
Health Authority: Canada: Ethics Review Committee

ClinicalTrials.gov processed this record on April 17, 2014