An Electronic Data Capture Study to Assess the Long-term Performance of the DePuy PROXIMA™ Hip in Primary Total Hip Replacement

Rheumatoid Arthritis Clinical Trial

Official title:

Prospective, International Multi-centre, Uncontrolled, Post Marketing Surveillance Study to Monitor the Long-term Performance of the DePuy PROXIMA™ Hip in Subjects With Indications Suitable for a Primary Total Hip Arthroplasty

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01134445
• Other study ID #: CT07/02
• Status: Terminated
• Phase: Phase 4
• First received: March 5, 2010
• Last updated: June 23, 2017
• Start date: February 1, 2010
• Est. completion date: June 1, 2016

Study information

• Verified date: June 2017
• Source: DePuy International
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to monitor the performance of the DePuy PROXIMA™ hip in the treatment of patients with hip joint disease requiring a total hip replacement. Patients who enter the study will be evaluated at regular intervals following hip surgery using patient, clinical and x-ray assessments.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 42
• Est. completion date: June 1, 2016
• Est. primary completion date: January 1, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Male or female subjects between 18 and 70 years of age.

• Subjects who are able to give voluntary, written informed consent to participate in this investigation and from whom consent has been obtained.

• Subjects who, in the opinion of the Investigator, are able to understand this investigation, co-operate with the investigational procedures and agree to return to the hospital for all the required post-operative follow-ups.

• Subjects who are scheduled to undergo a primary THR whom the surgeon considers to be suitable for the DePuy PROXIMATM hip femoral prosthesis.

Exclusion Criteria:

• Subjects with active local or systemic infection

• Subjects with loss of musculature, neuromuscular compromise or vascular deficiency in the affected limb rendering the procedure unjustified.

• Subjects with poor bone quality, such as osteoporosis, where, in the surgeon's opinion, there could be considerable migration of the prosthesis or a significant chance of fracture of the femoral shaft and/or the lack of adequate bone to support the implant(s).

• Subjects with Charcot's or Paget's disease.

• Subjects with hip dysplasia with severe neck anteversion or severe dysplasia of the proximal femur.

• Subjects with severe osteoporosis.

• Subjects with previous proximal femoral fractures.

• Subjects who, in the opinion of the Investigator, have an existing condition/co-morbidity or infection that would compromise their long-term participation and follow-up in this study.

• Women who are pregnant.

• Subjects who are known drug or alcohol abusers or with psychological disorders that could affect follow-up care or treatment outcomes.

• Subjects who have participated in a clinical study with an investigational product in the last 6 month(s).

• Subjects who are currently involved in any injury litigation claims.

• Subjects for whom the surgical procedure is a revision of a previous THR, hemi-arthroplasty or hip resurfacing

• Subjects who have previously undergone osteotomy or arthrodesis of the hip.

• Subjects undergoing a simultaneous bilateral hip operation.

• Subjects undergoing the second stage of a staged bilateral for whom the contralateral hip is part of this clinical investigation.

• Subjects undergoing the second stage of a staged bilateral for whom the contralateral hip was implanted less than six months previously or is not performing satisfactorily

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Avascular Necrosis
• Congenital Hip Dysplasia
• Femoral Fractures
• Hip Dislocation
• Hip Dislocation, Congenital
• Necrosis
• Osteoarthritis
• Post-traumatic Arthritis
• Rheumatoid Arthritis
• Traumatic Femoral Fractures

Intervention

Device:
• DePuy Proxima™ Hip
A short, anatomic, cementless femoral component for use in total hip arthroplasty

Locations

Country	Name	City	State
France	Hospital Belle Isle	Metz
Portugal	Hospital de Santo Antonio	Porto
Spain	Hospital Clinic Barcelona	Barcelona
United Kingdom	Pilgrim Hospital	Boston

Sponsors (1)

Lead Sponsor	Collaborator
DePuy International

Countries where clinical trial is conducted

France,  Portugal,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Kaplan-Meier survivorship calculated at the five-year time-point		5yrs post surgery
Secondary	Annual Kaplan-Meier survivorship calculations		1yr post-surgery
Secondary	Harris Hip Score		6mths post-surgery
Secondary	Oxford Hip Score		3mths post-surgery
Secondary	UCLA Activity Score		3mths post-surgery
Secondary	Hip Outcome Score		3mths post-surgery
Secondary	EuroQol EQ-5D		3mths post-surgery
Secondary	Annual Kaplan-Meier survivorship calculations		2yrs post-surgery
Secondary	Annual Kaplan-Meier survivorship calculations		3yrs post-surgery
Secondary	Annual Kaplan-Meier survivorship calculations		4yrs post-surgery
Secondary	Annual Kaplan-Meier survivorship calculations		6yrs post-surgery
Secondary	Annual Kaplan-Meier survivorship calculations		7yrs post-surgery
Secondary	Annual Kaplan-Meier survivorship calculations		8yrs post-surgery
Secondary	Annual Kaplan-Meier survivorship calculations		9yrs post-surgery
Secondary	Annual Kaplan-Meier survivorship calculations		10yrs post-surgery
Secondary	Annual Kaplan-Meier survivorship calculations		11yrs post-surgery
Secondary	Annual Kaplan-Meier survivorship calculations		12yrs post-surgery
Secondary	Annual Kaplan-Meier survivorship calculations		13yrs post-surgery
Secondary	Annual Kaplan-Meier survivorship calculations		14yrs post-surgery
Secondary	Annual Kaplan-Meier survivorship calculations		15yrs post-surgery
Secondary	Harris Hip Score		1yr post-surgery
Secondary	Harris Hip Score		2yrs post-surgery
Secondary	Harris Hip Score		5yrs post-surgery
Secondary	Harris Hip Score		10yrs post-surgery
Secondary	Harris Hip Score		15yrs post-surgery
Secondary	Radiographic Analysis		3mths post-surgery
Secondary	Radiographic Analysis		6mths post-surgery
Secondary	Radiographic Analysis		1yr post-surgery
Secondary	Radiographic Analysis		2yrs post-surgery
Secondary	Radiographic Analysis		5yrs post-surgery
Secondary	Radiographic Analysis		10yrs post-surgery
Secondary	Radiographic Analysis		15 yrs post-surgery
Secondary	Oxford Hip Score		6mths post-surgery
Secondary	Oxford Hip Score		1yr post-sugery
Secondary	UCLA Activity Score		6mths post-surgery
Secondary	UCLA Activity Score		1yr post-surgery
Secondary	Hip Outcome Score		6mths post-surgery
Secondary	Hip Outcome Score		1yr post-surgery
Secondary	EuroQol EQ-5D		6mths post-surgery
Secondary	EuroQol EQ-5D		1yr post-surgery
Secondary	Oxford Hip Score		2yrs post-surgery
Secondary	Oxford Hip Score		3yrs post-surgery
Secondary	Oxford Hip Score		4yrs post-surgery
Secondary	Oxford Hip Score		5yrs post-surgery
Secondary	Oxford Hip Score		6yrs post-surgery
Secondary	Oxford Hip Score		7yrs post-surgery
Secondary	Oxford Hip Score		8yrs post-surgery
Secondary	Oxford Hip Score		9yrs post surgery
Secondary	Oxford Hip Score		10yrs post-surgery
Secondary	Oxford Hip Score		11yrs post-surgery
Secondary	Oxford Hip Score		12yrs post-surgery
Secondary	Oxford Hip Score		13yrs post-sugery
Secondary	Oxford Hip Score		14yrs post-surgery
Secondary	Oxford Hip Score		15yrs post-surgery
Secondary	UCLA Activity Score		2yrs post-surgery
Secondary	UCLA Activity Score		3yrs post-surgery
Secondary	UCLA Activity Score		4yrs post-surgery
Secondary	UCLA Activity Score		5yrs post-surgery
Secondary	UCLA Activity Score		6yrs post-surgery
Secondary	UCLA Activity Score		7yrs post-surgery
Secondary	UCLA Activity Score		8yrs post-surgery
Secondary	UCLA Activity Score		9yrs post-surgery
Secondary	UCLA Activity Score		10yrs post-surgery
Secondary	UCLA Activity Score		11yrs post-surgery
Secondary	UCLA Activity Score		12yrs post-surgery
Secondary	UCLA Activity Score		13yrs post-surgery
Secondary	UCLA Activity Score		14yrs post-surgery
Secondary	UCLA Activity Score		15yrs post-surgery
Secondary	Hip Outcome Score		2yrs post-surgery
Secondary	Hip Outcome Score		3yrs post-surgery
Secondary	Hip Outcome Score		4yrs post-surgery
Secondary	Hip Outcome Score		5yrs post-surgery
Secondary	Hip Outcome Score		6yrs post-surgery
Secondary	Hip Outcome Score		7yrs post-surgery
Secondary	Hip Outcome Score		8yrs post-surgery
Secondary	Hip Outcome Score		9yrs post-surgery
Secondary	Hip Outcome Score		10yrs post-surgery
Secondary	Hip Outcome Score		11yrs post-surgery
Secondary	Hip Outcome Score		12yrs post-surgery
Secondary	Hip Outcome Score		13yrs post-surgery
Secondary	Hip Outcome Score		14yrs post-surgery
Secondary	Hip Outcome Score		15yrs post-surgery
Secondary	EuroQol EQ-5D		2yrs post-surgery
Secondary	EuroQol EQ-5D		3yrs post-surgery
Secondary	EuroQol EQ-5D		4yrs post-surgery
Secondary	EuroQol EQ-5D		5yrs post-surgery
Secondary	EuroQol EQ-5D		6yrs post-surgery
Secondary	EuroQol EQ-5D		7yrs post-surgery
Secondary	EuroQol EQ-5D		8yrs post-surgery
Secondary	EuroQol EQ-5D		9yrs post-surgery
Secondary	EuroQol EQ-5D		10yrs post-surgery
Secondary	EuroQol EQ-5D		11yrs post-surgery
Secondary	EuroQol EQ-5D		12yrs post-surgery
Secondary	EuroQol EQ-5D		13yrs post-surgery
Secondary	EuroQol EQ-5D		14yrs post-surgery
Secondary	EuroQol EQ-5D		15yrs post-surgery