Ignite Creation Date:
2024-05-05 @ 11:57 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00196573
Status:
UNKNOWN
Last Update Posted:
2014-04-25
First Post:
2005-09-12
Brief Title:
Subacromial Decompression Versus Subacromial Bursectomy for Patients With Rotator Cuff Tendinosis
Sponsor:
University of Western Ontario Canada
Organization:
University of Western Ontario Canada
Study Overview
Official Title:
A Randomized Clinical Trial Comparing the Effectiveness of Subacromial Decompression Acromioplasty Versus Subacromial Bursectomy no Acromioplasty in the Arthroscopic Treatment of Patients With Rotator Cuff Tendinosis
Status:
UNKNOWN
Status Verified Date:
2014-04
Last Known Status:
ACTIVE_NOT_RECRUITING
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:
The purpose of this study is to compare the effectiveness of arthroscopic subacromial decompression acromioplasty to arthroscopic subacromial bursectomy no acromioplasty in rotator cuff impingement syndrome The investigators hypothesis is that arthroscopic subacromial decompression provides no additional benefit as evaluated with disease specific quality of life measures compared to arthroscopic bursectomy
Detailed Description:
The most commonly performed surgical procedure to treat rotator cuff tendinosis when no full-thickness tear exists is subacromial decompression acromioplasty This procedure is based on the theory that primary acromial morphology an extrinsic cause is the initiating factor leading to the dysfunction and eventual tearing of the rotator cuff
Subacromial decompression involves surgical excision of the subacromial bursa resection of the coracoacromial ligament resection of the anteroinferior portion of the acromion and resection of any osteophytes from the acromioclavicular joint that are thought to be contributing to impingement
Several studies have indicated that the vast majority of partial-thickness tears are found on the articular surface of the rotator cuff which is not in keeping with the theory that rotator cuff impingement is primarily a result of acromion morphology
Burkhart proposed that pathologic changes in the supraspinatus tendon occur primarily as a result of overuse and tension overload an intrinsic factor resulting in superior migration of the humeral head during active elevation
Budoff et al suggest that since the coracoacromial ligament stabilizes the rotator cuff to prevent uncontrolled superior migration of the humeral head resection of the coracoacromial ligament during arthroscopic subacromial decompression may cause in the long-term additional proximal migration of the humeral head
Arthroscopic bursectomy with debridement of rotator cuff tears alone without acromioplasty addresses the primary anatomical pathology and may offer similar success rates to subacromial decompression without the risk of future instability caused by resection of the acromion and coracoacromial ligament
Subacromial decompression involves surgical excision of the subacromial bursa resection of the coracoacromial ligament resection of the anteroinferior portion of the acromion and resection of any osteophytes from the acromioclavicular joint that are thought to be contributing to impingement
Several studies have indicated that the vast majority of partial-thickness tears are found on the articular surface of the rotator cuff which is not in keeping with the theory that rotator cuff impingement is primarily a result of acromion morphology
Burkhart proposed that pathologic changes in the supraspinatus tendon occur primarily as a result of overuse and tension overload an intrinsic factor resulting in superior migration of the humeral head during active elevation
Budoff et al suggest that since the coracoacromial ligament stabilizes the rotator cuff to prevent uncontrolled superior migration of the humeral head resection of the coracoacromial ligament during arthroscopic subacromial decompression may cause in the long-term additional proximal migration of the humeral head
Arthroscopic bursectomy with debridement of rotator cuff tears alone without acromioplasty addresses the primary anatomical pathology and may offer similar success rates to subacromial decompression without the risk of future instability caused by resection of the acromion and coracoacromial ligament
Study Oversight
Has Oversight DMC:
None
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| WillitsYIG1 | None | None | None |