- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02655848
Tenotomy or Tenodesis of Long Head Biceps in Arthroscopic Rotator Cuff Repair (BITE)
Long Head Biceps Tenodesis or Tenotomy in Arthroscopic Rotator Cuff Repair: An International Multicenter Prospective Randomized Clinical Trial
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Amsterdam, Netherlands, 1066EC
- Slootervaart ziekenhuis
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Amsterdam, Netherlands, 1075BG
- Kliniek De Lairesse
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Amsterdam, Netherlands, 1090HM
- OLVG
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Apeldoorn, Netherlands, 7334DZ
- Gelre Ziekenhuis
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Breda, Netherlands, 4819JV
- Amphia Ziekenhuis
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Gouda, Netherlands, 2803HH
- Groene Hart Ziekenhuis
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Hilversum, Netherlands
- Tergooi ziekenhuizen
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Hoofddorp, Netherlands
- Spaarne Ziekenhuis
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Nieuwegein, Netherlands, 3430EM
- St Antonius
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Nijmegen, Netherlands
- Canisius Wilehelmina Zkh
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: @ 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.
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Arthroscopic rotator cuff repair using suture anchors
Arthroscopic tenotomy and subsequent fixation of long head biceps proximal in the biceps groove
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Active Comparator: @ 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.
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Arthroscopic rotator cuff repair using suture anchors
Arthroscopic tenotomy of long head biceps
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Shoulder function quantified with the Constant score (0-100)
Time Frame: 1 year
|
Sum of the items below: ADL: Patient reported shoulder function during work (0-4), recreation/sports (0-4), and sleep (0-2). Pain: Patient reported pain in the shoulder (severe=0,moderate=5,mild=10,no pain=15). ROM: Anteflexion up to waist(2)/xiphoid process(4)/neck(6)/head(8)/above head(10) Elevation in degrees: 0-30(0)/31-60(2)/61-90(4)/91-120(6)/121-150(8)/151-180(10) Abduction in degrees: 0-30(0)/31-60(2)/61-90(4)/91-120(6)/121-150(8)/151-180(10) External rotation: impossible to reach head with hand(0)/hand behind head-elbow forward(2)/hand behind head-elbow backward(4)/hand on head-elbow forward(6)/hand on head-elbow backward(8)/full elevation hand from head(10) Internal rotation: dorsal part of the hand reaching lateral thigh(0)/buttock(2)/lumbo-sacral junction(4)/L3(6)/Th12(8)/between scapulae(10). Abduction force at 90 degrees in pounds (max. 25) |
1 year
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Popeye phenomenon
Time Frame: 1 year
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Presence of a Popeye deformity in the upper arm (yes/no), as reported by the patient, the treating surgeon, and a blinded assessor.
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1 year
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Cosmetic appearance
Time Frame: 1 year
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Patients will assess cosmetic appearance on a VAS scale.
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1 year
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MRI-based location of the biceps tendon
Time Frame: 1 year
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MRI imaging at 1 year after surgery will be used to assess the location of the proximal biceps tendon.
Absence of the biceps tendon in the bicipital groove confirms a successfully performed LHB tenotomy.
Absence of the biceps tendon in the bicipital groove confirms failed LHB tendodesis.
In addition, the rotator cuff is classified as fully healed, partially healed or recurrent rupture.
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1 year
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Self-reported shoulder function
Time Frame: 1 year
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Patients will complete two validated questionnaires: the Disabilities of Arm, Shoulder and Hand Questionnaire (DASH) and the Dutch Oxford Shoulder Test (DOST)
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1 year
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Pain
Time Frame: 1 year
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Patients will be asked to report if they have pain (yes/no), and to indicate the level of pain on a VAS scale.
The VAS scores will be recorded separately for general pain and for pain in the bicipital groove.
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1 year
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Elbow flexion strength
Time Frame: 1 year
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A dynamometer will be used to assess elbow flexion strength with the lower arm in full supination.
The Elbow Strength Index is calculated by dividing the strength in the affected side by the strength in the contralateral side.
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1 year
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Quality of life
Time Frame: 1 year
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Patients will complete the validated questionnaire 'EQ-5D', which covers 5 domains (mobility, personal care, daily activities, pain and mood), as well as a 100 point thermometer on general health.
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1 year
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Post-operative status of rotator cuff
Time Frame: 1 year
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Based on MRI imaging at 1 year after surgery, the rotator cuff is classified as fully healed, partially healed or recurrent rupture.
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1 year
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Duration of surgery
Time Frame: 1 year
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The duration of surgery will be calculated based on the start and end times of each surgery.
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1 year
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Complications
Time Frame: 1 year
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All complications and serious adverse events in the study population are recorded.
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1 year
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Derek van Deurzen, MD, OLVG
Publications and helpful links
General Publications
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- WO 10.087
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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