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NCT Number: NCT02655848

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

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.

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Key information

Conditions

Rotator Cuff Syndrome

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kliniek De Lairesse, Amsterdam, Netherlands

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Arthroscopic Rotator Cuff Repair

Procedure

Arthroscopic rotator cuff repair using suture anchors

LHB Tenodesis

Procedure

Arthroscopic tenotomy and subsequent fixation of long head biceps proximal in the biceps groove

LHB Tenotomy

Procedure

Arthroscopic tenotomy of long head biceps

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Onze Lieve Vrouwe Gasthuis

Other

Collaborators

  • Nederlandse Vereniging voor Arthroscopie
  • Smith & Nephew, Inc.

Registry information

Official study title

Long Head Biceps Tenodesis or Tenotomy in Arthroscopic Rotator Cuff Repair: An International Multicenter Prospective Randomized Clinical Trial

Acronym: BITE

Important dates

Study start
2012
Primary completion
2019
Study completion
2019
First posted
Jan 14, 2016
Registry last updated
Oct 1, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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