Condition category
Musculoskeletal Diseases
Date applied
06/05/2012
Date assigned
31/05/2012
Last edited
23/06/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

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

Trial website

Contact information

Type

Scientific

Primary contact

Prof Olimpio Galasso

ORCID ID

Contact details

Dept. of Medical and Surgical Sciences
University Magna Graecia
Catanzaro
88100
Italy
-
galasso@unicz.it

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Tenotomy versus tenodesis in the treatment of the long head of biceps brachii tendon lesions: a randomized controlled study

Acronym

Study hypothesis

Most 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

Ethics Committee of the “Azienda Ospedaliera Mater Domini”, Catanzaro, Italy, ref: 2011-57

Study design

Two-center randomised double-blind controlled study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Lesions of the long head of the biceps brachii tendon (LHBT)

Intervention

The 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 type

Procedure/Surgery

Phase

Drug names

Primary outcome measures

Constant-Murley scores (CMS) at the two-year follow-up

Secondary outcome measures

1. General health evaluated by Short Form 36 (SF-36) score
2. The number and severity of complications

Overall trial start date

01/01/2012

Overall trial end date

01/01/2015

Reason abandoned

Lack of funding/sponsorship

Eligibility

Participant inclusion criteria

1. 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

128

Participant exclusion criteria

1. 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

Recruitment start date

01/01/2012

Recruitment end date

01/01/2015

Locations

Countries of recruitment

Italy

Trial participating centre

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

Sponsor information

Organisation

Hospital Mater Domini (Azienda Ospedaliera Mater Domini) (Italy)

Sponsor details

Via T. Campanella
115
Catanzaro
88100
Italy
+39 (0)961 712111
protocollo@aomaterdomini.it

Sponsor type

Hospital/treatment centre

Website

http://www.aomaterdomini.it/comitatoEtico.php

Funders

Funder type

University/education

Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2012 results in: www.ncbi.nlm.nih.gov/pubmed/23088416

Publication citations

  1. Results

    Galasso O, Gasparini G, De Benedetto M, Familiari F, Castricini R, Tenotomy versus tenodesis in the treatment of the long head of biceps brachii tendon lesions., BMC Musculoskelet Disord, 2012, 13, 205, doi: 10.1186/1471-2474-13-205.

Additional files

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.