Dual Mobility Cup in Total Hip Arthroplasty Preventing Di... | NCT01644227

Studies
Dual Mobility Cup in Total Hip Arthroplasty Preventing Dislocation in Patients at Risk

NCT01644227

Sponsor

Sundsvall Hospital

Status

Completed

Last Update Posted

May 13, 2016Estimated

Enrollment

34Actual

Phase

Not provided

Conditions

Femoral Neck Fracture
Osteoarthritis

Interventions

Not provided

Countries

Sweden

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

Oct 2015

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

Jun 2012

Primary Completion Date

Jul 2012Actual

Completion Date

Jul 2012Actual

First Submitted Date

Jun 24, 2012

First Submission Date that Met QC Criteria

Jul 16, 2012

First Posted Date

Jul 19, 2012Estimated

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

May 11, 2016

Last Update Posted Date

May 13, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

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

Retrospectively study reviewing 34 patients operated with dual mobility cups in total hip arthroplasty between January 2009 and June 2012 at Sundsvall Hospital.

Hypothesis: The dual mobility socket reduce the rate of dislocation in patient at high risk but increase the incidence of postoperative infection.

Detailed Description

Retrospectively study reviewing 34 patients operated with dual mobility cups in total hip arthroplasty between January 2009 and June 2012 at Sundsvall Hospital.

Indications for surgery is recurrent dislocation or patients at risk for dislocation after total hip arthroplasty suffering osteoarthritis or femoral neck fracture.

Patients are followed recording complications, reoperations, functional outcome (Harris hip score and EQ5D) in june 2012.

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

34Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Prosthetic dislocation	Incidence of postoperative dislocations of the prosthesis	2012 (up to 3 years postoperatively)

Secondary Outcomes

Measure	Description	Time Frame
Complication	Incidence of complications and reoperations	2012 (up to 3 years postoperatively)
Hip function	Patient reported hip function; Harris hip score

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

operated with an cemented dual mobility socket at Sundsvall hospital

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

All patients operated with an cemented dual mobility cups at Sundsvall hospital between 2009-2012.

Indications for surgery are recurrent dislocation and patients at risk for dislocation mainly due to comorbidity, neuromuscular, psychiatric or cognitive disorders.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Arkan S Sayed Noor, MD, PhD	Landstinget Västernorrland	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Orthopaedic department		Sundsvall	Västernorrland County	851 86	Sweden

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
23888200	Result	Mukka SS, Mahmood SS, Sjoden GO, Sayed-Noor AS. Dual mobility cups for preventing early hip arthroplasty dislocation in patients at risk: experience in a county hospital. Orthop Rev (Pavia). 2013 Jun 11;5(2):48-51. doi: 10.4081/or.2013.e10. Print 2013 Jun 7.

ID	Term
D005265	Femoral Neck Fractures
D010003	Osteoarthritis
D004204	Joint Dislocations

ID	Term
D006620	Hip Fractures
D005264	Femoral Fractures
D050723	Fractures, Bone
D014947	Wounds and Injuries