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Long head biceps tenodesis or tenotomy in arthroscopic rotator cuff repair: An international multicenter prospective randomized clinical trial.

Long head biceps tenodesis or tenotomy in arthroscopic rotator cuff repair: An international multicenter prospective randomized clinical trial. - BITE

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON44133
Enrollment
98
Registered
2012-07-12
Start date
2013-03-07
Completion date
Unknown
Last updated
2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Long head bicepstendon pathology rotatorcuff surgery

Interventions

In addition to arthroscopic rotator cuff repair one group is treated by performing LHB tenotomy and the other group is treated by performing an LHB tenodesis.

Sponsors

Onze Lieve Vrouwe Gasthuis
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Patients older than 50 years who are indicated to undergo repair of a moderately sized rotator cuff (infraspinatus and/or supraspinatus) tendon rupture (sized smaller than 3cm measured using an arthroscopic ruler), who are encountered with an inflamed, unstable or partially torn LHB tendon. 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

Exclusion criteria: Patients are excluded form this study in case of an 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. Patients are also excluded when the origo of the bicepstendon has an hour-glass aspect or in case of accompanying subscapularis tendon rupture. Pre-operative X-ray of the involved shoulder revealing acromion to humeral head distance measuring 6mm or smaller or osteoarthritis also excludes patients from participation to this study. Any prior surgery to the involved shoulder leads to exclusion from participation in this study. Dementia or inability to complete questionnaires and assessments excludes patients form this study as well.

Design outcomes

Primary

MeasureTime frame
Patient evaluation is conducted with a focus on overall shoulder function, as evaluated with the Constant score. In addition, the Dutch Oxford Shoulder Test and the Disabilities of the Arm Shoulder and Hand questionnaire will be assessed.

Secondary

MeasureTime frame
Other evaluations concern: cosmetic appearance evaluated by the **Popeye** deformity, arm cramping pain, elbow flexion strength (measured with a hand dynamometer), and quality of life and cost-utility (evaluated with the EQ-5D).

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)