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Bicepspees tenodese of tenotomie bij arthroscopische rotator cuff repair: Een internationaal multicenter prospectief gerandomiseerde klinische trial.

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON20398
Enrollment
98
Registered
2012-01-18
Start date
2012-06-01
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

Rotator cuff, Arthroscopic treatment, Bicepstendon, Popeye, Cosmesis

Interventions

Long head biceps tenodesis or tenotomy in arthroscopic rotator cuff repair.

Sponsors

OLVG Amsterdam
Lead Sponsor

Eligibility

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. (This excludes patients who have a massive rotator cuff rupture, since these patients are more likely to have a re-rupture within one year). 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
Functional outcome measured using the Constant score.

Secondary

MeasureTime frame
In addition, the Dutch Oxford Shoulder Test (DOST) and the Disabilities of the Arm Shoulder and Hand (DASH) questionnaire will be assessed. Other evaluations concern: cosmetic appearance evaluated by the ‘‘Popeye’’ deformity, arm cramping pain, elbow flexion strength (measured with a hand dynamometer), cost-effectiveness (evaluated with the EQ-5D), and an MRI evaluation.

Contacts

Public ContactD.F.P. Deurzen, van

Postbus 95500

d.vandeurzen@olvg.nl+31205993277

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)