Tenotomy or Tenodesis of Long Head Biceps in Arthroscopic Rotator Cuff Repair
NCT ID: NCT02655848
Last Updated: 2019-10-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
98 participants
INTERVENTIONAL
2012-07-31
2019-09-30
Brief Summary
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Detailed Description
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Primary outcome is overall shoulder function evaluated with the Constant score. As additional measures of shoulder function, the Dutch Oxford Shoulder Test and the Disabilities of the Arm Shoulder and Hand questionnaire will be assessed. Other evaluations include cosmetic appearance evaluated by the ''Popeye'' deformity, arm cramping pain, elbow flexion strength, MRI evaluation, quality of life, and cost of surgery. To detect non-inferiority with a one-sided, two-sample t-test with a 80% power and a significance level (alpha) of 0.025, the required sample size is 98 patients.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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@ Cuff repair with LHB tenodesis
In case of pathologic changes of the long Head Biceps tendon, a tenodesis is performed in adjunct to performing an arthroscopic rotator cuff repair.
Arthroscopic rotator cuff repair
Arthroscopic rotator cuff repair using suture anchors
LHB Tenodesis
Arthroscopic tenotomy and subsequent fixation of long head biceps proximal in the biceps groove
@ cuff repair with LHB tenotomy
In case of pathologic changes of the long Head Biceps tendon, a tenotomy is performed in adjunct to performing an arthroscopic rotator cuff repair.
Arthroscopic rotator cuff repair
Arthroscopic rotator cuff repair using suture anchors
LHB Tenotomy
Arthroscopic tenotomy of long head biceps
Interventions
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Arthroscopic rotator cuff repair
Arthroscopic rotator cuff repair using suture anchors
LHB Tenodesis
Arthroscopic tenotomy and subsequent fixation of long head biceps proximal in the biceps groove
LHB Tenotomy
Arthroscopic tenotomy of long head biceps
Eligibility Criteria
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Inclusion Criteria
* Degenerative rotator cuff lesion of supraspinatus/infraspinatus tendon, smaller than three centimeter.
* Patients need to be able to read and write in Dutch or English language in order to complete the questionnaires, and sign informed consent.
Exclusion Criteria
* Accompanying subscapularis tendon lesion
* Hour-glass deformation bicepstendon origin or in case of accompanying subscapularis tendon rupture.
* Osteoarthritis of the glenohumeral joint
* Acromion to humeral head distance measuring 6mm or smaller.
* Prior surgery to the involved shoulder
* Dementia or inability to complete questionnaires and assessments
50 Years
ALL
Yes
Sponsors
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Nederlandse Vereniging voor Arthroscopie
UNKNOWN
Smith & Nephew, Inc.
INDUSTRY
Onze Lieve Vrouwe Gasthuis
OTHER
Responsible Party
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DFP van Deurzen
Orthopedic Surgeon
Principal Investigators
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Derek van Deurzen, MD
Role: PRINCIPAL_INVESTIGATOR
OLVG
Locations
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Slootervaart ziekenhuis
Amsterdam, , Netherlands
Kliniek De Lairesse
Amsterdam, , Netherlands
OLVG
Amsterdam, , Netherlands
Gelre ziekenhuis
Apeldoorn, , Netherlands
Amphia ziekenhuis
Breda, , Netherlands
Groene Hart Ziekenhuis
Gouda, , Netherlands
Tergooi Ziekenhuizen
Hilversum, , Netherlands
Spaarne Ziekenhuis
Hoofddorp, , Netherlands
St Antonius
Nieuwegein, , Netherlands
Canisius Wilehelmina Zkh
Nijmegen, , Netherlands
Countries
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References
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Gurnani N, van Deurzen DF, Janmaat VT, van den Bekerom MP. Tenotomy or tenodesis for pathology of the long head of the biceps brachii: a systematic review and meta-analysis. Knee Surg Sports Traumatol Arthrosc. 2016 Dec;24(12):3765-3771. doi: 10.1007/s00167-015-3640-6. Epub 2015 May 15.
Zhang Q, Zhou J, Ge H, Cheng B. Tenotomy or tenodesis for long head biceps lesions in shoulders with reparable rotator cuff tears: a prospective randomised trial. Knee Surg Sports Traumatol Arthrosc. 2015 Feb;23(2):464-9. doi: 10.1007/s00167-013-2587-8. Epub 2013 Jul 5.
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 Oct 22;13:205. doi: 10.1186/1471-2474-13-205.
van Deurzen DF, Scholtes VA, Willigenburg NW, Gurnani N, Verweij LP, van den Bekerom MP; BITE collaboration group. Long head BIceps TEnodesis or tenotomy in arthroscopic rotator cuff repair: BITE study protocol. BMC Musculoskelet Disord. 2016 Aug 30;17(1):375. doi: 10.1186/s12891-016-1230-5.
Other Identifiers
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WO 10.087
Identifier Type: -
Identifier Source: org_study_id
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