NCT01635166

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.

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for phase_4 rheumatoid-arthritis

Timeline
Completed

Started Jul 2012

Longer than P75 for phase_4 rheumatoid-arthritis

Geographic Reach
2 countries

3 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 6, 2012

Completed
5 months until next milestone

Study Start

First participant enrolled

July 1, 2012

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 9, 2012

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 8, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 8, 2018

Completed
Last Updated

July 19, 2018

Status Verified

July 1, 2018

Enrollment Period

5.6 years

First QC Date

February 6, 2012

Last Update Submit

July 18, 2018

Conditions

Rheumatoid ArthritisOsteoarthritisPost-traumatic ArthritisAvascular NecrosisTraumatic Femoral FracturesCongenital Hip Dysplasia

Keywords

ArthroplastyReplacementHipCementlessCeramic on Ceramic

Outcome Measures

Primary Outcomes (1)

  • Kaplan-Meier survivorship

    To determine survivorship of the DeltaMotion Cup System at 3 years

    3 years

Secondary Outcomes (6)

  • Kaplan-Meier survivorship

    10yrs post-surgery

  • Harris Hip Score

    10yrs post-surgery

  • Oxford Hip Score

    10yrs post-surgery

  • University of California Los Angeles (UCLA) Score

    10yrs post-surgery

  • Western Ontario and McMaster Universities (WOMAC) Score

    10yrs post-surgery

  • +1 more secondary outcomes

Study Arms (1)

Delta Motion

OTHER

A cementless acetabular cup with a pre-assembled ceramic liner for use in total hip replacement

Device: Delta Motion

Interventions

Delta MotionDEVICE

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

Delta Motion

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Apollo Speciality hospital, 320 Anna Salai

Chennai, 600035, India

Location

All India Institute of Medical Sciences, Ansari nagar, South Extension

New Dehli, 110029, India

Location

Robert Jones and Agnes Hunt

Oswestry, United Kingdom

Location

MeSH Terms

Conditions

Arthritis, RheumatoidOsteoarthritisOsteonecrosisHip Dislocation, Congenital

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesBone DiseasesNecrosisPathologic ProcessesPathological Conditions, Signs and SymptomsDevelopmental Dysplasia of the HipMusculoskeletal AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 6, 2012

First Posted

July 9, 2012

Study Start

July 1, 2012

Primary Completion

February 8, 2018

Study Completion

February 8, 2018

Last Updated

July 19, 2018

Record last verified: 2018-07

Locations

GB(1)IN(2)