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

NCT02062450 | Completed Results

• 1 other identifier: 1204-T-DOUBLEMOB-RM
• Study Type: observational
• Target: 379
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

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

Keywords

Arthroplasty; Hip Replacement; Acetabular cup; Dual mobility; Hip revision surgery

Outcome Measures

Primary Outcomes (3)

• Number of Participants With an Implant Dislocation After Surgery

  The primary safety outcome (implant dislocation) was assessed by a single question to the patients : Did you experience any implant dislocation since your surgery ? Positive answers were quantified.

  2-year postoperative

• Percentage of Participants With an Implant Dislocation After Surgery (= Dislocation Rate)

  The primary safety outcome (implant dislocation) was assessed by a single question to the patients : Did you experience any implant dislocation since your surgery ? Positive answers were quantified.

  2-year postoperative

• Implant Survivorship

  Implant survivorship criteria was assessed by investigators during patients visits : is the implanted device still in place 2 years after surgery ? Negative answers were quantified.

  2-year postoperative

Secondary Outcomes (3)

• Clinical Performance - PMA Score

  2 years postoperative

• Clinical Performance - HOOS Score

  2 years postoperative

• Clinical Performance - HARRIS Score

  2-year postoperative

Study Arms (2)

Primary surgery with Dual Mobility Cup

Patients having a Primary Hip acetabular replacement, using a Dual Mobility Cup.

Device: Primary surgery with Dual Mobility Cup

Revision surgery with Dual Mobility Cup

Patients having a Revision Hip acetabular replacement, using a Dual Mobility Cup.

Device: Revision surgery with Dual Mobility Cup

Interventions

Primary surgery with Dual Mobility Cup DEVICE

Hip joint replacement with a hip prosthesis including a Dual Mobility cup to replace the acetabular component.

Primary surgery with Dual Mobility Cup

Revision surgery with Dual Mobility Cup DEVICE

Hip joint replacement with a hip prosthesis including a Dual Mobility cup to replace the acetabular component.

Revision surgery with Dual Mobility Cup

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The global cohort: All the patients who received a Tornier Dual Mobility acetabular cup between October 2010 and October 2011 and who we were able to be contacted by phone. "Primary replacement" group: All the patients who received a Tornier Dual Mobility acetabular cup between October 2010 and October 2011 for primary hip replacement and who were seen for their follow-up visit at 2 years post-procedure. "Revision" group: All patients who received a Tornier Dual Mobility acetabular cup between October 2010 and October 2011 for revision surgery and who were seen for their follow-up visit at 2 years post-procedure. All the performance criteria were analysed for the patients in the "Primary replacement" and "Revision" groups

You may qualify if:

• 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.

You may not qualify if:

• patients with tumoral pathology.

Sponsors & Collaborators

• Stryker Trauma and Extremities: lead

MeSH Terms

Conditions

Femur Head Necrosis; Femoral Neck Fractures

Interventions

Reoperation

Condition Hierarchy (Ancestors)

Osteonecrosis; Bone Diseases; Musculoskeletal Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hip Fractures; Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Results Point of Contact

• Title: Nathalie TRETOUT
• Organization: TORNIER SAS

nathalie.tretout@tornier.com

+33 4 76 71 35 00

Study Officials

• Christophe Hulet, MD, PR

  Caen University Hospital, FR

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2014
• First Posted: February 13, 2014
• Study Start: May 1, 2013
• Primary Completion: November 1, 2013
• Study Completion: December 1, 2013
• Last Updated: May 4, 2017
• Results First Posted: May 16, 2016

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share