Contact information
Type
Scientific
Primary contact
Prof Olimpio Galasso
ORCID ID
Contact details
University Magna Graecia - Dept. of Medical and Surgical Sciences
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 below 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
Postoperative differences in Constant-Murley scores (CMS) between the two groups at the two-year follow-up
Secondary outcome measures
1. Evaluation of the general health of patients in both groups as evaluated by Short Form 36 (SF-36) scores
2. The number and severity of complications associated with the investigational surgical techniques will be assessed
Overall trial start date
01/01/2012
Overall trial end date
01/01/2015
Reason abandoned
Lack of funding/sponsorship
Eligibility
Participant inclusion criteria
Male or female patients patients, aged 18 years or older, with 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
Results - basic reporting
Publication summary
1. 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.