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

Phase 4

Terminated

• Conditions: Osteoarthritis; Rheumatoid Arthritis; Post-traumatic Arthritis; Avascular Necrosis; Traumatic Femoral Fractures; Congenital Hip Dysplasia
• Interventions: Device: Delta Motion

• Registration Number: NCT01635166
• Lead Sponsor: DePuy International

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-02-06
• Study Start: 2012-07-01
• Study First Submitted QC: 2012-07-03
• Study First Posted: 2012-07-09
• Primary Completion: 2018-02-08
• Study Completion: 2018-02-08
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-18
• Last Update Posted: 2018-07-19

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Delta Motion	Delta Motion	A cementless acetabular cup with a pre-assembled ceramic liner for use in total hip replacement

Primary Outcome Measures

Name	Time	Method
Kaplan-Meier survivorship	3 years	To determine survivorship of the DeltaMotion Cup System at 3 years

Secondary Outcome Measures

Name	Time	Method
Western Ontario and McMaster Universities (WOMAC) Score	10yrs post-surgery	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
Kaplan-Meier survivorship	10yrs post-surgery	To determine survivorship of the DeltaMotion Cup System at 10 years
Radiological analysis	10yrs post-surgery	* 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.
Oxford Hip Score	10yrs post-surgery	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.
Harris Hip Score	10yrs post-surgery	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.
University of California Los Angeles (UCLA) Score	10yrs post-surgery	Change from baseline in the UCLA Quality of Life Score. UCLA is a patient completed outcome score used in hip replacement

Trial Locations

Locations (3)

Apollo Speciality hospital, 320 Anna Salai; 🇮🇳 Chennai, India

All India Institute of Medical Sciences, Ansari nagar, South Extension; 🇮🇳 New Dehli, India

Robert Jones and Agnes Hunt; 🇬🇧 Oswestry, United Kingdom