Clinical trial NCT02655848: Tenotomy or Tenodesis of Long Head Biceps in Arthroscopic Rotator Cuff Repair
Official title: Long Head Biceps Tenodesis or Tenotomy in Arthroscopic Rotator Cuff Repair: An International Multicenter Prospective Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rotator Cuff Syndrome
Keywords: Popeye
Long Head Biceps Tendon
Arthroscopy
Functional result
Lead sponsor: Onze Lieve Vrouwe Gasthuis
Sponsor class: OTHER
Collaborators: name: Nederlandse Vereniging voor Arthroscopie
name: Smith & Nephew, Inc.
First posted: 2016-01-14
Enrollment: 98
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: During arthroscopic rotator cuff (infraspinatus/supraspinatus) repair, biceps tendon lesions are frequently encountered. However, the most optimal treatment of the diseased long head of the biceps (LHB) tendon during rotator cuff repair remains a topic of debate: tenotomy or tenodesis. The hypothesis is that there is no difference in functional outcome between LHB tenotomy and LHB tenodesis when performed in adjunct to arthroscopic rotator cuff repair.

Detailed description: Patients older than 50 years with a supraspinatus and/or infraspinatus tendon rupture sized smaller than 3cm, who are encountered with LHB pathology, will be randomized to either LHB tenotomy or LHB tenodesis. Clinical and self-reported data will be collected pre-operatively, and 6 weeks, 3 months, and 1 year after surgery.

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.

Eligibility criteria: Inclusion Criteria:

* Patients older than 50 years
* 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:

* Acute, traumatic or partial thickness rotator cuff rupture, or in case a full thickness tear is larger than 3 cm measured using an arthroscopic ruler.
* 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

Primary outcomes:
measure: Shoulder function quantified with the Constant score (0-100)
timeFrame: 1 year
Secondary outcomes:
measure: Popeye phenomenon
timeFrame: 1 year
measure: Cosmetic appearance
timeFrame: 1 year
measure: MRI-based location of the biceps tendon
timeFrame: 1 year
measure: Self-reported shoulder function
timeFrame: 1 year
measure: Pain
timeFrame: 1 year
measure: Elbow flexion strength
timeFrame: 1 year
measure: Quality of life
timeFrame: 1 year
measure: Post-operative status of rotator cuff
timeFrame: 1 year
measure: Duration of surgery
timeFrame: 1 year
measure: Complications
timeFrame: 1 year
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Slootervaart ziekenhuis
city: Amsterdam
country: Netherlands
facility: Kliniek De Lairesse
city: Amsterdam
country: Netherlands
facility: OLVG
city: Apeldoorn
country: Netherlands
facility: Gelre ziekenhuis
city: Breda
country: Netherlands
facility: Amphia ziekenhuis
city: Gouda
country: Netherlands
facility: Groene Hart Ziekenhuis
city: Hilversum
country: Netherlands
facility: Tergooi Ziekenhuizen
city: Hoofddorp
country: Netherlands
facility: Spaarne Ziekenhuis
city: Nieuwegein
country: Netherlands
facility: St Antonius
city: Nijmegen
country: Netherlands
facility: Canisius Wilehelmina Zkh
Study officials:
affiliation: OLVG
name: Derek van Deurzen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.