Clinical trial NCT01635166: Multi-centre Study to Assess the Long-term Performance of the Deltamotion Cup System in Primary Hip Replacement Surgery
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Rheumatoid Arthritis
Osteoarthritis
Post-traumatic Arthritis
Avascular Necrosis
Traumatic Femoral Fractures
Congenital Hip Dysplasia
Keywords: Arthroplasty
Replacement
Hip
Cementless
Ceramic on Ceramic
Lead sponsor: DePuy International
Sponsor class: INDUSTRY
First posted: 2012-07-09
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Kaplan-Meier survivorship
timeFrame: 3 years
Secondary outcomes:
measure: Kaplan-Meier survivorship
timeFrame: 10yrs post-surgery
measure: Harris Hip Score
timeFrame: 10yrs post-surgery
measure: Oxford Hip Score
timeFrame: 10yrs post-surgery
measure: University of California Los Angeles (UCLA) Score
timeFrame: 10yrs post-surgery
measure: Western Ontario and McMaster Universities (WOMAC) Score
timeFrame: 10yrs post-surgery
measure: Radiological analysis
timeFrame: 10yrs post-surgery
Other outcomes:
Locations:
city: Chennai
country: India
facility: Apollo Speciality hospital, 320 Anna Salai
city: New Dehli
country: India
facility: All India Institute of Medical Sciences, Ansari nagar, South Extension
city: Oswestry
country: United Kingdom
facility: Robert Jones and Agnes Hunt
Study officials:
References: