N/A N=379

Observational Study Evaluating Outcomes of Hip Arthroplasty Using Tornier Dual Mobility Acetabular Cup

Primary Osteoarthritis · Post-traumatic Osteoarthritis of Hip Nos · Femur Head Necrosis · Femur Neck Fracture · Congenital Dislocations

Bottom Line

View on ClinicalTrials.gov: NCT02062450 ↗

Enrolled (actual)

379

Serious AEs

2.5%

Results posted

May 2016

Primary outcome: Primary: Number of Participants With an Implant Dislocation After Surgery — 2 participants

Study Design & Population

Study type: Observational
Phase: N/A
Interventions: Primary surgery with Dual Mobility Cup (Device); Revision surgery with Dual Mobility Cup (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Stryker Trauma and Extremities
Primary completion: Nov 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With an Implant Dislocation After Surgery	2	—
PRIMARY Percentage of Participants With an Implant Dislocation After Surgery (= Dislocation Rate)	0.53	—
PRIMARY Implant Survivorship	99.5	—
SECONDARY Clinical Performance - PMA Score	10.8; 9.3; 16.4; 15.2; 6.1; 5.9	—
SECONDARY Clinical Performance - HOOS Score	91.8; 86.4; 87.5; 84.5; 84.2; 76.6	—
SECONDARY Clinical Performance - HARRIS Score	64; 40; 13; 16; 10; 19	—

Summary

The purpose of this study is to demonstrate the performance and reliability of Tornier "Dual Mobility Cup" used during primary total hip replacement or hip replacement revision surgery at least 24 months post-insertion.

Eligibility Criteria

Inclusion Criteria

men and women aged over 18, undergoing total hip replacement with insertion of a Dual Mobility acetabular cup between October 2010 and October 2011,
capable of attending the 2-year follow-up visit;
capable of understanding the information about the study and agreeing to take part in it.

Exclusion Criteria

patients with tumoral pathology.

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Data sourced from ClinicalTrials.gov (NCT02062450). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.