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

Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01644227
• Other study ID #: Sebastian-1
• Status: Completed
• Phase: N/A
• First received: June 24, 2012
• Last updated: May 11, 2016
• Start date: June 2012
• Est. completion date: July 2012

Study information

• Verified date: October 2015
• Source: Sundsvall Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• operated with an cemented dual mobility socket at Sundsvall hospital

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Dislocations
• Femoral Neck Fracture
• Femoral Neck Fractures
• Osteoarthritis

Locations

Country	Name	City	State
Sweden	Orthopaedic department	Sundsvall	Västernorrlands län

Sponsors (1)

Lead Sponsor	Collaborator
Sundsvall Hospital

Country where clinical trial is conducted

Sweden, 

References & Publications (1)

Mukka SS, Mahmood SS, Sjödén 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prosthetic dislocation	Incidence of postoperative dislocations of the prosthesis	2012 (up to 3 years postoperatively)	Yes
Secondary	Complication	Incidence of complications and reoperations	2012 (up to 3 years postoperatively)	Yes
Secondary	Hip function	Patient reported hip function; Harris hip score	2012 (up to 3 years postoperatively)	No
Secondary	Quality of life	Patient reported quality of life: EQ5D	2012 (up to 3 years postoperatively)	No