Biceps Tenodesis Versus Tenotomy

NCT ID: NCT01747902

Last Updated: 2020-09-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 112 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2020-05-31

Brief Summary

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.

Detailed Description

Methodology

Patients will be screened in clinic and, if deemed appropriate for the study, will be approached by the research coordinator who will review the study and provide the opportunity for consenting to participate. The surgical procedure will be performed using standard arthroscopic technique and patients will be randomized intra-operatively via computer randomization when a biceps tendon lesion is confirmed. The type of anchor for the tenodesis, whether bioabsorbable or metal, and the manufacture of the anchor used is at the discretion of the surgeon. Duration of the surgery will be between 60-120 minutes.

Surgical Technique

The technique can be done using a biceps groove or a subpectoral level of fixation depending on surgeon preference. Shoulder arthroscopy is conducted in the lateral decubitus or beach chair position. Diagnostic arthroscopy is performed using a standard posterior portal and the biceps tendon is assessed with an arthroscopic probe using a standard anterior interval portal. Once study eligibility was confirmed via identification of tearing or degeneration of the long head of biceps, the patient was randomized to undergo either tenodesis or tenotomy.

For patients who undergo biceps tenotomy the long head of biceps tendon is detached from its proximal anchor to the superior labrum using an arthroscopic biter, an electrothermal device, or a scalpel based on individual surgeon preference.

For those patients undergoing biceps tenodesis, the tendon is tagged with a monofilament suture prior to detaching it from its superior labral attachment. The long head of biceps is then mobilized arthroscopically, and retrieved through an incision either in the groove (which is opened arthroscopically in the subacromial space) or at the inferior border of the pectoralis major tendon. A No. 2 non-absorbable suture is whip-stitched at the appropriate length. The remainder of the biceps tendon is excised and the anterior cortex of the proximal humerus is prepared using a cannulated reamer inserted into the bicipital groove. One suture limb is then passed through an appropriate size interference screw and the tendon is placed within the reamed tunnel. The screw is then advanced until it is flush with bone..

Once the long head of biceps tendon pathology had been addressed, the scope is switched to a standard lateral portal to assess subacromial pathology and the rotator cuff. Subacromial decompression is performed using a cutting block technique if required, and the rotator cuff is repaired if necessary using standard anterolateral and posterolateral accessory portals based on tear configuration.

Post-operative Care and Physiotherapy

Postoperative care and immobilization are identical for the two groups and consist of the use of an immobilizer for 4-6 weeks. Patients are allowed to remove the immobilizer for activities of daily living in which the arm is not abducted and does not externally rotate beyond neutral. Active range of motion is started at 4-6 weeks and resistance exercises are begun when maximal range of motion has been achieved. No at-risk work activities or sports are allowed for six months.

Data Analysis

The primary analysis involves a comparison of the mean ASES scores between the two surgical treatment groups on an intention to treat basis. This analysis is a two sample independent t-test to assess whether there is a statistically significant difference between groups for the mean ASES scores at baseline and each follow-up appointment up to two years. Repeated measures ANOVAs will be used to determine the effect of surgery from baseline to two years post-surgery (i.e. pre-operatively, 3, 6, and 12, and 24 month follow-ups) on ASES scores for each group. The 5% significance level is employed. The underlying assumption for the ASES score data is that there is a normal distribution. If the sample distribution is determined to depart from normal, then a Wilcoxon rank sum test with Bonferroni correction will be performed. The secondary analysis involves a comparison of the secondary outcome measures between the two surgical treatment groups. The elbow strength findings will be analyzed for differences between the two groups at each time point up to 2 years. Repeated measures ANOVAs will be used to determine the effect of surgery from baseline to two years post-surgery (i.e. pre-operatively, 3, 6, and 12, and 24 month follow-ups) on ASES and elbow strength for each group. Nominal demographic data will be compared using the chi-squared test, while ordinal data will be compared using a t-test.

Significance of the Proposed Research

Arthroscopic treatment of lesions of the long head of the biceps tendon, whether tenodesis or tenotomy, has shown consistently favourable results. This trial is necessary both to provide optimal care of our patients, and to do so in a fiscally responsible fashion as the biceps tenodesis procedure has potential cost implications related to additional surgical time and anchor requirements. The results of the trial will provide valuable information regarding the management of lesions of the long head of the biceps tendon. The data obtained from quality of life measurements and physical exam will enable the authors to make recommendations that will lead to maximizing shoulder function and quality of life in patients.

Conditions

Rotator Cuff Tear; Long Head of Biceps Brachii Lesions

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Biceps tenodesis

The biceps tenodesis group will have their bicep detached and then re-inserted onto the shoulder.

Group Type: OTHER

Biceps Tenodesis

Intervention Type: PROCEDURE

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.

Group Type: OTHER

Biceps Tenotomy

Intervention Type: PROCEDURE

The biceps tenotomy group will have their bicep treated by detaching the tendon from the shoulder.

Interventions

Biceps Tenotomy

The biceps tenotomy group will have their bicep treated by detaching the tendon from the shoulder.

Intervention Type: PROCEDURE

Biceps Tenodesis

The biceps tenodesis group will have their bicep detached and then re-inserted onto the shoulder.

Intervention Type: PROCEDURE

Eligibility 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.

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

Sponsors

University of Ottawa

OTHER

Sponsor Role: collaborator

Panam Clinic

OTHER

Sponsor Role: lead

Responsible Party

Peter MacDonald

Department Head, Orthopaedics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Peter MacDonald, MD FRCSC

Role: PRINCIPAL_INVESTIGATOR

Pan Am Clinic

Locations

Pan Am Clinic

Winnipeg, Manitoba, Canada

Countries

Canada

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Other Identifiers

B2012:113

Identifier Type: -

Identifier Source: org_study_id