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

• Sponsor: DePuy International (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT01635166
• Collaborator: (none)
• Enrollment: 250
• Locations: 3
• Arm: 1
• Actual Duration (Months): 67.3
• Patients Per Site: 83.3
• Patients Per Site Per Month: 1.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Rheumatoid Arthritis; Osteoarthritis; Post-traumatic Arthritis; Avascular Necrosis; Traumatic Femoral Fractures; Congenital Hip Dysplasia	Device: Delta Motion	Phase 4

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 250 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Jul 1, 2012
• Actual Primary Completion Date: Feb 8, 2018
• Actual Study Completion Date: Feb 8, 2018

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Kaplan-Meier survivorship [3 years]

   To determine survivorship of the DeltaMotion Cup System at 3 years

Secondary Outcome Measures

1. Kaplan-Meier survivorship [10yrs post-surgery]

   To determine survivorship of the DeltaMotion Cup System at 10 years

2. 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.

3. 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.

4. 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

5. 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

6. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria

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

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

3. 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.

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

Exclusion Criteria

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

2. Women who are pregnant.

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

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

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Apollo Speciality hospital, 320 Anna Salai	Chennai		India	600035
2	All India Institute of Medical Sciences, Ansari nagar, South Extension	New Dehli		India	110029
3	Robert Jones and Agnes Hunt	Oswestry		United Kingdom

Sponsors and Collaborators

• DePuy International

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: DePuy International
• ClinicalTrials.gov Identifier: NCT01635166
• Other Study ID Numbers: CT11/01
• First Posted: Jul 9, 2012
• Last Update Posted: Jul 19, 2018
• Last Verified: Jul 1, 2018

• Keywords provided by DePuy International: Arthroplasty; Replacement; Hip; Cementless; Ceramic on Ceramic
• Additional relevant MeSH terms: Arthritis; Hip Dislocation; Developmental Dysplasia of the Hip; Hip Dislocation, Congenital; Necrosis; Femoral Fractures

Study Results

No Results Posted as of Jul 19, 2018