Condition category
Musculoskeletal Diseases
Date applied
06/05/2012
Date assigned
31/05/2012
Last edited
18/07/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Lay summary under review 2

Trial website

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

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

1. 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

18/07/2016: the trial was stopped due to lack of funding, and at intermediate follow-up there was no difference between techniques.