Outcomes After Repair of Acute Rotator Cuff Tears | NCT01140230

Studies
Outcomes After Repair of Acute Rotator Cuff Tears

NCT01140230

Sponsor

University Hospital, Linkoeping

Status

Completed

Last Update Posted

Jun 9, 2010Estimated

Enrollment

42Actual

Phase

Not provided

Conditions

Rotator Cuff Tear

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2009

Primary Completion Date

May 2010Actual

Completion Date

May 2010Actual

First Submitted Date

Jun 8, 2010

First Submission Date that Met QC Criteria

Jun 8, 2010

First Posted Date

Jun 9, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 8, 2010

Last Update Posted Date

Jun 9, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Few studies are considering acute traumatic rotator cuff tears in previously asymptomatic patients. The purpose of the current study was to investigate if delay of surgery, age at repair and the number of cuff tendons involved affected the structural and clinical outcomes.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

42Actual

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

significant trauma to the shoulder
sudden onset of symptoms
asymptomatic in the shoulder before trauma
pseudoparalysis in the shoulder after trauma
full thickness rotator cuff tear of at least one tendon

Exclusion Criteria:

patients with previous or gradual onset of symptoms in the traumatised shoulder
partial rotator cuff tear
displaced fracture

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

42 Years

Maximum Age

83 Years

Standard Ages

AdultOlder Adult

Study Population

A retrospective review of our computerized database identified 49 patients repaired at our institution between May 2004 until May 2009 due to acute traumatic rotator cuff tears. 42 patients who fulfilled the inclusion criteria, were willing to participate in a follow-up evaluation after written and oral informed consent.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Lars Adolfsson, Associate Professor	Department of Orthopeadic, Linkoeping University Hospital	Study Director

Locations

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
6839586	Background	Bassett RW, Cofield RH. Acute tears of the rotator cuff. The timing of surgical repair. Clin Orthop Relat Res. 1983 May;(175):18-24.
17621294	Background	Lahteenmaki R, Lawrence S. Public biotech 2006 - the numbers. Nat Biotechnol. 2007 Jul;25(7):729-37. doi: 10.1038/nbt0707-729. No abstract available.

ID	Term
D012421	Rupture
D014947	Wounds and Injuries
D000070599	Shoulder Injuries
D013708	Tendon Injuries