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Tenotomy of long head biceps tendon as a treatment for elderly patients with degenerative rotator cuff rupture.

Tenotomy of long head biceps tendon as a treatment for elderly patients with degenerative rotator cuff rupture. - LOBI-trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON43623
Enrollment
126
Registered
2015-12-10
Start date
2016-01-01
Completion date
Unknown
Last updated
2024-04-23

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

Conditions

rotator cuff rupture Shoulder tendon tear

Interventions

Not applicable.

Sponsors

Deventer Ziekenhuis
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1) Age 65 years and older. 2) Clinical suspicion rotator cuff rupture with pain and/or weakness while testing supraspinatus tendon and/or infraspinatus tendon. 3) MRI of the affected shoulder, assessed by two evaluators as full thickness suprasprinatus and/or infraspinatus rupture with retraction at least grade 2 according to the scale of Patte and intact non-dislocated long head biceps tendon. 4) Signed informed consent.

Exclusion criteria

Exclusion criteria: 1) Frozen shoulder (in more than 3 directions less than 50% of the normal range of motion, passive examination) 2) Symptomatic AC-artrosis on the ipsilateral side. 3) (Reumatoïd) arthritis 4) Diabetes Mellitus (type 1 and 2). 5) Language barrier or cognitive problem (not able to fill in the questionnaires). 5) Neurologic problems with functional shoulder complaints. 6) Surgical treatment in the past in the same shoulder. 7) Glenohumoral osteoarthritis 8) Inclusion of the contralateral shoulder in this study.

Design outcomes

Primary

MeasureTime frame
Primary outcome measure is the Constant-Murley Score. With this as outcome measure we can compare the results to the current literature.

Secondary

MeasureTime frame
Secondary outcome is the Oxford Shoulder Score. Other questionnaires/tests where patients will be exposed to are the VAS pain score, EQ-5D questionnaire, Anchor questions questionnaire and the O'Brien test at the physical examination. We will also determine the size and anatomical location of the rotator cuff rupture on the MRI.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)