NCT01644227

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2012

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2012

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

June 24, 2012

Completed
7 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
18 days until next milestone

First Posted

Study publicly available on registry

July 19, 2012

Completed
Last Updated

May 13, 2016

Status Verified

October 1, 2015

Enrollment Period

1 month

First QC Date

June 24, 2012

Last Update Submit

May 11, 2016

Conditions

Femoral Neck FractureOsteoarthritis

Keywords

Hip surgerydual mobility cupdislocationtotal hip arthroplasty

Outcome Measures

Primary Outcomes (1)

  • Prosthetic dislocation

    Incidence of postoperative dislocations of the prosthesis

    2012 (up to 3 years postoperatively)

Secondary Outcomes (3)

  • Complication

    2012 (up to 3 years postoperatively)

  • Hip function

    2012 (up to 3 years postoperatively)

  • Quality of life

    2012 (up to 3 years postoperatively)

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • operated with an cemented dual mobility socket at Sundsvall hospital

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Orthopaedic department

Sundsvall, Västernorrland County, 851 86, Sweden

Location

Related Publications (1)

  • 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.

    PMID: 23888200RESULT

MeSH Terms

Conditions

Femoral Neck FracturesOsteoarthritisJoint Dislocations

Condition Hierarchy (Ancestors)

Hip FracturesFemoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg InjuriesArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Arkan S Sayed Noor, MD, PhD

    Landstinget Västernorrland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 24, 2012

First Posted

July 19, 2012

Study Start

June 1, 2012

Primary Completion

July 1, 2012

Study Completion

July 1, 2012

Last Updated

May 13, 2016

Record last verified: 2015-10

Locations

SE(1)