UnknownNot Applicable

Irreparable Rotator Cuff Tears Treatment. Comparison of Two Methods: With and Without Biceps Tendon Augmentation

Poland90 participantsStarted 2019-01-30

Plain-language summary

Management of massive rotator cuff tears (MRCT) is associated with high rates of failure. The long head of the biceps tendon augmentation (LHBTA) by reinforcement of the reconstruction and additional blood supply may improve healing and provide better outcome than partial repair only.

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: Massive and irreparable rotator cuff tear: * chronic supraspinatus tear with retraction grade 3 and muscle fatty infiltration ( measured in MRI ) \> 3\* * Infraspinatus tear with retraction and fatty muscle degeneration Exclusion Criteria: * Previosus surgery * Imposibility to performed MRI * Diabetes * no compliance

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Comparison of improvement in shoulder range of motion

Timeframe: Through study completion, an average of 2.5 years

Comparison of improvement in shoulder strength

Timeframe: Through study completion, an average of 2.5 years

Comparison of improvement in shoulder pain in VAS score

Timeframe: Through study completion, an average of 2.5 years

Comparison of shoulder function measured in Constant-Murley Score

Timeframe: Through study completion, an average of 2.5 years

Comparison of shoulder function measured in SST Score

Timeframe: Through study completion, an average of 2.5 years

Trial details

NCT IDNCT05001581

SponsorSaint Lucas Hospital, Poland

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-01-01

Contact for this trial

Hubert Laprus, MD

+48 691 891 274 hubert.laprus@gmail.com

View on ClinicalTrials.gov More Massive Rotator Cuff Tears trials

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Comparison of improvement in shoulder range of motion

Timeframe: Through study completion, an average of 2.5 years

Comparison of improvement in shoulder strength

Timeframe: Through study completion, an average of 2.5 years

Comparison of improvement in shoulder pain in VAS score

Timeframe: Through study completion, an average of 2.5 years

Comparison of shoulder function measured in Constant-Murley Score

Timeframe: Through study completion, an average of 2.5 years

Comparison of shoulder function measured in SST Score

Timeframe: Through study completion, an average of 2.5 years