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 measure
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 (if study stopped)
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
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
Basic results (scientific)
Publication list
2012 results in: www.ncbi.nlm.nih.gov/pubmed/23088416
Publication citations
-
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.