NCT00208390

Brief Summary

The purpose of this study is to monitor the performance of the Summit™ hip 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

63
Monitor

Trial Health Score

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

Enrollment
275

participants targeted

Target at P75+ for phase_4 rheumatoid-arthritis

Timeline
Completed

Started Feb 2003

Longer than P75 for phase_4 rheumatoid-arthritis

Geographic Reach
5 countries

5 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

Study Start

First participant enrolled

February 1, 2003

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 21, 2005

Completed
6.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
Last Updated

August 4, 2016

Status Verified

July 1, 2016

Enrollment Period

9.3 years

First QC Date

September 13, 2005

Last Update Submit

August 3, 2016

Conditions

Rheumatoid ArthritisOsteoarthritisPost-traumatic ArthritisCollagen DisordersAvascular NecrosisTraumatic Femoral FracturesNonunion of Femoral FracturesCongenital Hip DysplasiaSlipped Capital Femoral Epiphysis

Keywords

HipCementless

Outcome Measures

Primary Outcomes (1)

  • Kaplan-Meier survivorship calculated at the five-year time point

    5yrs post-surgery

Secondary Outcomes (6)

  • Kaplan-Meier survivorship calculations

    Annually

  • Harris Hip score

    6mths, 1yr, 2yrs, 3yrs, 5yrs, 7yrs, 10yrs and 15yrs post-surgery

  • Oxford score

    6mths and Annually post-surgery

  • UCLA activity rating

    6mths and Annually post-surgery

  • Thigh pain analysis

    6mths and Annually post-surgery

  • +1 more secondary outcomes

Study Arms (1)

Summit Tapered Hip System

OTHER

A cementless, tapered femoral component for use in total hip replacement

Device: Summit Tapered Hip System

Interventions

Summit Tapered Hip SystemDEVICE

A cementless, tapered femoral component for use in total hip replacement

Summit Tapered Hip System

Eligibility Criteria

Age18 Years - 70 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 investigation and from whom consent has been obtained.
  • iii) Subjects who, in the opinion of the Investigator, are able to understand this 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 who require primary total hip replacement and are considered suitable for a cementless femoral stem.

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 study.
  • ii) Subjects who have previously undergone a hemi-arthroplasty or total hip arthroplasty.
  • iii) Women who are pregnant.
  • iv) Subjects who are known drug or alcohol abusers or with psychological disorders that could effect follow-up care or treatment outcomes.
  • v) Subjects who have participated in a clinical study with an investigational product in the last 12 months.
  • vi) Subjects who are currently involved in any injury litigation claims.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

2. Ruijin Hospital

Shanghai, China

Location

3. The University of Hong Kong at Queen Mary Hospital

Pokfulam, Hong Kong

Location

1. Ospedale Riuniti Di Bergamo

Bergamo, Italy

Location

5. Middlemore Hospital

Auckland, New Zealand

Location

4. Yonsei University College of Medicine

Seoul, South Korea

Location

MeSH Terms

Conditions

Arthritis, RheumatoidOsteoarthritisCollagen DiseasesOsteonecrosisHip Dislocation, CongenitalSlipped Capital Femoral Epiphyses

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 AbnormalitiesOsteochondrodysplasiasBone Diseases, DevelopmentalEpiphyses, Slipped

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

September 13, 2005

First Posted

September 21, 2005

Study Start

February 1, 2003

Primary Completion

May 1, 2012

Study Completion

May 1, 2012

Last Updated

August 4, 2016

Record last verified: 2016-07

Locations

NZ(1)IT(1)KR(1)CN(1)HK(1)