Ignite Creation Date:
2025-12-25 @ 2:44 AM
Ignite Modification Date:
2026-02-28 @ 5:28 AM
Study NCT ID:
NCT01829633
Status:
COMPLETED
Last Update Posted:
2018-01-23
First Post:
2013-04-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Anatomic and Clinical Long-term Follow-up of Conservatively Treated Rotator Cuff Tears
Sponsor:
Vestre Viken Hospital Trust
Organization:
Study Overview
Official Title:
Anatomic and Clinical Long-term Follow-up of Conservatively Treated Rotator Cuff Tears
Status:
COMPLETED
Status Verified Date:
2018-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Study population: Patients who have been treated with physiotherapy for a potentially repairable rotator cuff tear in the period from 2002 to 2005.
Study Method: At the time of diagnosis (2002 to 2005) all study patients were examined clinically, sonographically and by MRI. Some patients also completed a shoulder score. All study patients will now be reexamined, 8 to 10 years after they were diagnosed. Reexamination includes history taking, clinical examination, completion of three shoulder scores (two shoulder specific scores, one general health score), Sonography and MRI. Findings of interest are
* the number of relapses during follow-up,
* the need for surgical treatment during follow-up,
* the deterioration of tear anatomy (tear size, muscle atrophy, fatty degeneration) during follow-up
* the actual clinical shoulder condition (as given by shoulder scores) at reexamination.
Study purpose: We want to assess the anatomic and clinical long-term results of physiotherapy for potentially repairable rotator cuff tears. We want to find out if tear anatomy of unrepaired rotator cuff tears deteriorates over time and if such a deterioration is associated with a development of more serious degrees of symptoms.
Study Method: At the time of diagnosis (2002 to 2005) all study patients were examined clinically, sonographically and by MRI. Some patients also completed a shoulder score. All study patients will now be reexamined, 8 to 10 years after they were diagnosed. Reexamination includes history taking, clinical examination, completion of three shoulder scores (two shoulder specific scores, one general health score), Sonography and MRI. Findings of interest are
* the number of relapses during follow-up,
* the need for surgical treatment during follow-up,
* the deterioration of tear anatomy (tear size, muscle atrophy, fatty degeneration) during follow-up
* the actual clinical shoulder condition (as given by shoulder scores) at reexamination.
Study purpose: We want to assess the anatomic and clinical long-term results of physiotherapy for potentially repairable rotator cuff tears. We want to find out if tear anatomy of unrepaired rotator cuff tears deteriorates over time and if such a deterioration is associated with a development of more serious degrees of symptoms.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2011/1931 | OTHER | Regional Committees for Medical and Health Research Ethics | View |