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Tenotomy or Tenodesis of Long Head Biceps in Arthroscopic Rotator Cuff Repair (BITE)

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ClinicalTrials.gov Identifier: NCT02655848
Recruitment Status : Recruiting
First Posted : January 14, 2016
Last Update Posted : March 13, 2019
Sponsor:
Collaborators:
Nederlandse Vereniging voor Arthroscopie
Smith & Nephew, Inc.
Information provided by (Responsible Party):
DFP van Deurzen, Onze Lieve Vrouwe Gasthuis

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.

Condition or disease Intervention/treatment Phase
Rotator Cuff Syndrome Procedure: Arthroscopic rotator cuff repair Procedure: LHB Tenodesis Procedure: LHB Tenotomy Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 98 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Long Head Biceps Tenodesis or Tenotomy in Arthroscopic Rotator Cuff Repair: An International Multicenter Prospective Randomized Clinical Trial
Study Start Date : July 2012
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : December 2019

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.
Procedure: Arthroscopic rotator cuff repair
Arthroscopic rotator cuff repair using suture anchors

Procedure: LHB Tenodesis
Arthroscopic tenotomy and subsequent fixation of long head biceps proximal in the biceps groove

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.
Procedure: Arthroscopic rotator cuff repair
Arthroscopic rotator cuff repair using suture anchors

Procedure: LHB Tenotomy
Arthroscopic tenotomy of long head biceps




Primary Outcome Measures :
  1. 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)



Secondary Outcome Measures :
  1. Popeye phenomenon [ Time Frame: 1 year ]
    Presence of a Popeye deformity in the upper arm (yes/no), as reported by the patient, the treating surgeon, and a blinded assessor.

  2. Cosmetic appearance [ Time Frame: 1 year ]
    Patients will assess cosmetic appearance on a VAS scale.

  3. MRI-based location of the biceps tendon [ Time Frame: 1 year ]
    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.

  4. Self-reported shoulder function [ Time Frame: 1 year ]
    Patients will complete two validated questionnaires: the Disabilities of Arm, Shoulder and Hand Questionnaire (DASH) and the Dutch Oxford Shoulder Test (DOST)

  5. Pain [ Time Frame: 1 year ]
    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.

  6. Elbow flexion strength [ Time Frame: 1 year ]
    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.

  7. Quality of life [ Time Frame: 1 year ]
    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.

  8. Post-operative status of rotator cuff [ Time Frame: 1 year ]
    Based on MRI imaging at 1 year after surgery, the rotator cuff is classified as fully healed, partially healed or recurrent rupture.

  9. Duration of surgery [ Time Frame: 1 year ]
    The duration of surgery will be calculated based on the start and end times of each surgery.

  10. Complications [ Time Frame: 1 year ]
    All complications and serious adverse events in the study population are recorded.



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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02655848


Contacts
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Contact: Lukas Verweij +31-205992415 l.p.e.verweij@olvg.nl
Contact: Nienke Willigenburg, PhD +31-205992415 n.w.willigenburg@olvg.nl

Locations
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Netherlands
Slootervaart ziekenhuis Recruiting
Amsterdam, Netherlands, 1066EC
Contact: Lijkele Beimers, MD    +31-205129333    lijkele.beimers@slz.nl   
Kliniek De Lairesse Recruiting
Amsterdam, Netherlands, 1075BG
Contact: Jaap Willems, MD, PhD    +31-206640206    wjwillems@kdl.nl   
OLVG Recruiting
Amsterdam, Netherlands, 1090HM
Contact: Derek van Deurzen, MD    +31-205992415    d.vandeurzen@olvg.nl   
Gelre ziekenhuis Recruiting
Apeldoorn, Netherlands, 7334DZ
Contact: Eric Raven, MD    +31-555818181    e.raven@gelre.nl   
Amphia ziekenhuis Recruiting
Breda, Netherlands, 4819JV
Contact: Maaike vd Borne, MD    +_31-765955000    mvdborne@amphia.nl   
Groene Hart Ziekenhuis Recruiting
Gouda, Netherlands, 2803HH
Contact: Ron Onstenk, MD    +31182505050    ron.onstenk@ghz.nl   
Tergooi Ziekenhuizen Not yet recruiting
Hilversum, Netherlands
Contact: Domique Baas, PhD    +31 88 753 5023    dbaas@tergooi.nl   
Contact: Roeland Riedijk, MD       rriedijk@gmail.com   
Spaarne Ziekenhuis Recruiting
Hoofddorp, Netherlands
Contact: Arthur van Noort, MD, PhD       a.vannoort@spaarneziekenhuis.nl   
St Antonius Recruiting
Nieuwegein, Netherlands, 3430EM
Contact: Jacco Zijl, MD    088-3203000    j.zijl@antoniusziekenhuis.nl   
Canisius Wilehelmina Zkh Recruiting
Nijmegen, Netherlands
Contact: Jacco Jenner, MD       j.jenner@cwz.nl   
Sponsors and Collaborators
Onze Lieve Vrouwe Gasthuis
Nederlandse Vereniging voor Arthroscopie
Smith & Nephew, Inc.
Investigators
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Principal Investigator: Derek van Deurzen, MD OLVG

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: DFP van Deurzen, Orthopedic Surgeon, Onze Lieve Vrouwe Gasthuis
ClinicalTrials.gov Identifier: NCT02655848     History of Changes
Other Study ID Numbers: WO 10.087
First Posted: January 14, 2016    Key Record Dates
Last Update Posted: March 13, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by DFP van Deurzen, Onze Lieve Vrouwe Gasthuis:
Popeye
Long Head Biceps Tendon
Arthroscopy
Functional result