Multi-centre Study to Assess the Long-term Performance of the Deltamotion Cup System in Primary Hip Replacement Surgery

Rheumatoid Arthritis Clinical Trial

Official title:

A Multi-centre, Prospective, Uncontrolled Post Market Clinical Follow-up Study (PMCFS) to Monitor the Survival and Performance of the DeltaMotion Cup System in Subjects Requiring a Total Hip Replacement

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01635166
• Other study ID #: CT11/01
• Status: Terminated
• Phase: Phase 4
• Start date: July 1, 2012
• Est. completion date: February 8, 2018

Study information

• Verified date: July 2018
• 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 DeltaMotion cup system 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: 250
• Est. completion date: February 8, 2018
• Est. primary completion date: February 8, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria

i) Male or female subjects, aged between 18 and 70 years inclusive.

ii) Subjects who are able to give voluntary, written informed consent to participate in this Clinical Investigation and from whom consent has been obtained.

iii) Subjects who, in the opinion of the Investigator, are able to understand this Clinical Investigation, co-operate with the investigational procedures and are willing to return to the hospital for all the required post-operative follow-ups.

iv) Subjects suitable for a cementless total hip replacement using the DeltaMotion Cup System, in accordance with all applicable Instructions For Use

Exclusion Criteria

i) Subjects who, in the opinion of the Investigator, have an existing condition that would compromise their participation and follow-up in this Clinical Investigation.

ii) Women who are pregnant.

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

iv) Subjects who have participated in a Clinical Investigation with an investigational product in the last 12 months.

v) Subjects who are currently involved in any injury litigation claims.

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:
• Delta Motion
A cementless acetabular cup with a pre-assembled ceramic liner for use in total hip replacement.

Locations

Country	Name	City	State
India	Apollo Speciality hospital, 320 Anna Salai	Chennai
India	All India Institute of Medical Sciences, Ansari nagar, South Extension	New Dehli
United Kingdom	Robert Jones and Agnes Hunt	Oswestry

Sponsors (1)

Lead Sponsor	Collaborator
DePuy International

Countries where clinical trial is conducted

India,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Kaplan-Meier survivorship	To determine survivorship of the DeltaMotion Cup System at 3 years	3 years
Secondary	Kaplan-Meier survivorship	To determine survivorship of the DeltaMotion Cup System at 10 years	10yrs post-surgery
Secondary	Harris Hip Score	Change from baseline in the Harris Hip Score. The Harris Hip Score is used to measure the outcome of total hip replacement and covers the areas of pain, function, absence of deformity and range of motion.	10yrs post-surgery
Secondary	Oxford Hip Score	Change from baseline in the Oxford Hip Score. The Oxford hip score is a patient completed outcomes score which is designed to assess function and pain with patients undergoing hip replacement surgery.	10yrs post-surgery
Secondary	University of California Los Angeles (UCLA) Score	Change from baseline in the UCLA Quality of Life Score. UCLA is a patient completed outcome score used in hip replacement	10yrs post-surgery
Secondary	Western Ontario and McMaster Universities (WOMAC) Score	Change from baseline in the WOMAC. WOMAC is a patient complete outcome score to assess pain, disability and joint stiffness in Osteoarthritis of the hip and knee	10yrs post-surgery
Secondary	Radiological analysis	Acetabular Migration (vertical or horizontal) less than 5mm; Acetabular Migration (varus or valgus) less than 5 degrees; No loosening - absence of acetabular radiolucencies of greater than 2mm in two zones.	10yrs post-surgery