An interventional study of Brace and Normal sling in Supraspinatus Injury, sponsored by Christian Candrian. Completed at 1 site in Switzerland. Open to participants aged 18 Years to 72 Years. Per ClinicalTrials.gov, last updated 2023-09-07.
Sponsored by Christian Candrian · Not applicable, Interventional, and Treatment
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The patient undergoes arthroscopic surgery to treat rotator cuff injury. At the end of the surgery, the patient will be randomized into group A (brace) or group B (normal sling).
Both groups will be also treated according to standard of care with physiotherapy and progressive introduction of movements.
The patient undergoes arthroscopic surgery to treat rotator cuff injury. At the end of the surgery, the patient will be randomized into group A (brace) or group B (normal sling).
Both groups will then perform only passive movements according to pain for the first 6 weeks supported by the physiotherapy, according to standard therapy. The following six weeks passive movements will be associated with active movements . No brace nor normal sling will be used anymore.
Patients are in study for 6 months. During this period quality of life and pain questionnaires are submitted to the patients and a MRI will be done at the end of the study.
Christian Candrian is the lead sponsor of 7 studies on the registry; 4 are open to participants now.
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A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
After surgery the patient must wear the brace for 6 weeks, for the first 3 weeks during day and night and for the following 3 weeks only at night
Procedure: Brace
After surgery the patient must wear the normal sling for two weeks
Procedure: Normal sling
A brace to be weared according to protocol
A normal sling to be weared according to protocol
Efficacy in the rehabilitative therapy
The primary objective of the study is to evaluate two different rehabilitative therapies. Efficacy is measured with a pre and post MRI
Time frame: 6 months
Quality of life assessment
Evaluation of the quality of live in both groups through Constant Quality of Life questionnair up to 6 months
Time frame: 6 months
re-rupture rate of the supraspinatus tendon
Evaluation of the re-rupture of the supraspinatus tendon though a follow up MRI at 6 months
Time frame: 6 months
Plan to share: Undecided
No publications or documents are linked to this record.
Ran from Jan 2018 to primary completion in Jul 2023, 66 months.
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This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
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Christian Candrian