Surgery for long head of biceps brachii tendon lesions

ISRCTN ISRCTN38839558
DOI https://doi.org/10.1186/ISRCTN38839558
Secondary identifying numbers N/A
Submission date
06/05/2012
Registration date
31/05/2012
Last edited
23/06/2017
Recruitment status
Stopped
Overall study status
Stopped
Condition category
Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Background and study aims
The biceps, also known as the biceps brachii, is a two-headed muscle that lies on the upper arm between the shoulder and the elbow. It is attached to the bones of the shoulder and elbow by strong cords of fibrous tissue called tendons. Lesions (damage) of the long head of the biceps brachii tendon (LHBT) are common and when not adequately treated, they may be responsible for persistent pain as well as functional impairment of the shoulder. LHBT lesions can be isolated but are more frequently associated with more complex diseases, such as shoulder instability or supraspinatus tendon tears. The two most common surgical procedures for LHBT lesions are biceps tenotomy and biceps tenodesis. In biceps tenotomy the long head of the biceps tendon is released from its attachment in the shoulder joint, allowing it to fall down. In biceps tenodesis the biceps tendon is released from the shoulder joint and reattached to the arm bone. Currently, there is no consensus regarding the most effective surgical procedure due to the inconsistent results and the limitations of published studies. Some claim that tenotomy is superior, reporting satisfactory results in most of the patients treated with this technique. The advantages of tenotomy include its greater ease of execution, and when it is performed alone, it requires fewer restrictions after surgery with an earlier return to activity. Others report similarly good results in most patients treated with tenodesis of the LHB avoiding some of the most common complications associated with tenotomy, such as cramping of the brachial biceps muscle, retraction of the biceps tendon and strength decrease of the arm and forearm. The aim of this study is to compare the effectiveness of tenotomy and tenodesis in the treatment of LHBT lesions.

Who can participate?
Patients aged 18 or over with LHBT lesions associated with supraspinatus tendon tears

What does the study involve?
Participants are randomly allocated to undergo either long head biceps tenotomy or tenodesis and the outcomes of the two groups are compared.

What are the possible benefits and risks of participating?
The surgical treatments are routinely used in the centers involved in the study.

Where is the study run from?
1. Villa Verde Clinic (Italy)
2. Magna Græcia University (Italy)

When is the study starting and how long is it expected to run for?
January 2012 to January 2015

Who is funding the study?
Magna Græcia University (Italy)

Who is the main contact?
1. Prof. Olimpio Galasso
galasso@unicz.it
2. Prof. Giorgio Gasparini
gasparini@unicz.it
3. Dr Roberto Castricini
robertocastricini@tin.it

Contact information

Prof Olimpio Galasso
Scientific

Dept. of Medical and Surgical Sciences
University Magna Graecia
Catanzaro
88100
Italy

Email galasso@unicz.it

Study information

Study designTwo-center randomised double-blind controlled study
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details to request a patient information sheet
Scientific titleTenotomy versus tenodesis in the treatment of the long head of biceps brachii tendon lesions: a randomized controlled study
Study objectivesMost of the studies comparing the results of long head biceps (LHB) tenodesis and tenotomy are limited by methodologic deficiencies such as a retrospective design, low statistical power or a lack of patient randomization. To the best of our knowledge, there are no double-blind randomized controlled trials on this topic. The purpose of this study is to compare the effectiveness of tenodesis and tenotomy in the treatment of LHBT lesions.
Ethics approval(s)Ethics Committee of the “Azienda Ospedaliera Mater Domini”, Catanzaro, Italy, ref: 2011-57
Health condition(s) or problem(s) studiedLesions of the long head of the biceps brachii tendon (LHBT)
InterventionThe two most common procedures for LHBT lesions are biceps tenotomy and biceps tenodesis. Both procedures will be performed in the lateral decubitus position. A routine glenohumeral diagnostic arthroscopy will be performed through a standard posterior arthroscopic portal; lateral and rotator interval anterior portals will be used to complete the surgery. Reconstruction of the supraspinatus tendon tear will be always performed.

The surgeon will be aware of the type of surgery being performed, but the physicians who will take care of the follow-up visits and who will collect the pre- and post-operative data of patients will be blinded to the surgical technique used to treat the patients.
Intervention typeProcedure/Surgery
Primary outcome measureConstant-Murley scores (CMS) at the two-year follow-up
Secondary outcome measures1. General health evaluated by Short Form 36 (SF-36) score
2. The number and severity of complications
Overall study start date01/01/2012
Completion date01/01/2015
Reason abandoned (if study stopped)Lack of funding/sponsorship

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants128
Key inclusion criteria1. Male or female patients
2. Aged 18 or older
3. LHBT lesions (tenosynovitis, subluxation, dislocation or partial rupture of the tendon) associated with supraspinatus tendon tears
Key exclusion criteria1. Previous surgery of the affected shoulder
2. Insufficient comprehension of the Italian language to understand the trial features
3. Mental handicap
4. A lack of willingness to return for all scheduled follow-up visits
5. Participation in another study
6. Any previous upper extremity neurological disorder or diagnosis based upon physical examination
7. A life expectancy of less than 2 years
8. An ongoing insurance trial, lawsuit, or pending legal action for shoulder disease
Date of first enrolment01/01/2012
Date of final enrolment01/01/2015

Locations

Countries of recruitment

  • Italy

Study participating centre

University Magna Graecia
Dept. of Medical and Surgical Sciences
Catanzaro
88100
Italy

Sponsor information

Hospital Mater Domini (Azienda Ospedaliera Mater Domini) (Italy)
Hospital/treatment centre

Via T. Campanella, 115
Catanzaro
88100
Italy

Phone +39 (0)961 712111
Email protocollo@aomaterdomini.it
Website http://www.aomaterdomini.it/comitatoEtico.php
ROR logo "ROR" https://ror.org/03q658t19

Funders

Funder type

University/education

Magna Graecia University of Catanzaro (Italy) - Department of Surgical and Medical Science

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 22/10/2012 Yes No

Editorial Notes

23/06/2017: Plain English summary added.
18/07/2016: the trial was stopped due to lack of funding, and at intermediate follow-up there was no difference between techniques.