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

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

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.

Study Overview

• Status: Terminated
• Conditions: Osteoarthritis; Rheumatoid Arthritis; Avascular Necrosis; Post-traumatic Arthritis; Congenital Hip Dysplasia; Traumatic Femoral Fractures
• Intervention / Treatment: Device: Delta Motion

• Study Type: Interventional
• Enrollment (Anticipated): 250
• Phase: Phase 4

Contacts and Locations

Study Locations

• India
  • Chennai, India, 600035
    • Apollo Speciality hospital, 320 Anna Salai
  • New Dehli, India, 110029
    • All India Institute of Medical Sciences, Ansari nagar, South Extension
• United Kingdom
  • Oswestry, United Kingdom
    • Robert Jones and Agnes Hunt

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: Delta Motion; A cementless acetabular cup with a pre-assembled ceramic liner for use in total hip replacement	Device: Delta Motion; A cementless acetabular cup with a pre-assembled ceramic liner for use in total hip replacement.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Kaplan-Meier survivorship	To determine survivorship of the DeltaMotion Cup System at 3 years	3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Kaplan-Meier survivorship	To determine survivorship of the DeltaMotion Cup System at 10 years	10yrs post-surgery
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
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
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
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
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

Collaborators and Investigators

• Sponsor: DePuy International

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 1, 2012
• Primary Completion (ACTUAL): February 8, 2018
• Study Completion (ACTUAL): February 8, 2018

Study Registration Dates

• First Submitted: February 6, 2012
• First Submitted That Met QC Criteria: July 3, 2012
• First Posted (ESTIMATE): July 9, 2012

Study Record Updates

• Last Update Posted (ACTUAL): July 19, 2018
• Last Update Submitted That Met QC Criteria: July 18, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: Arthroplasty; Replacement; Hip; Cementless; Ceramic on Ceramic
• Additional Relevant MeSH Terms: Pathologic Processes; Fractures, Bone; Wounds and Injuries; Leg Injuries; Congenital Abnormalities; Joint Diseases; Musculoskeletal Diseases; Hip Injuries; Musculoskeletal Abnormalities; Joint Dislocations; Femoral Fractures; Arthritis; Necrosis; Hip Dislocation; Developmental Dysplasia of the Hip; Hip Dislocation, Congenital
• Other Study ID Numbers: CT11/01