Clinical trial NCT00208390: A Multi-centre Study to Assess the Long-term Performance of the Summit™ Hip in Primary Total Hip Replacement
Official title: Prospective, Uncontrolled, Multi-Centre, Post-Marketing Surveillance Study to Evaluate the Long-Term Performance of Summit Tapered Hip in Cementless Total Hip Arthroplasty
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Rheumatoid Arthritis
Osteoarthritis
Post-traumatic Arthritis
Collagen Disorders
Avascular Necrosis
Traumatic Femoral Fractures
Nonunion of Femoral Fractures
Congenital Hip Dysplasia
Slipped Capital Femoral Epiphysis
Keywords: Hip
Cementless
Lead sponsor: DePuy International
Sponsor class: INDUSTRY
First posted: 2005-09-21
Enrollment: 275
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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 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.

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 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.

Primary outcomes:
measure: Kaplan-Meier survivorship calculated at the five-year time point
timeFrame: 5yrs post-surgery
Secondary outcomes:
measure: Kaplan-Meier survivorship calculations
timeFrame: Annually
measure: Harris Hip score
timeFrame: 6mths, 1yr, 2yrs, 3yrs, 5yrs, 7yrs, 10yrs and 15yrs post-surgery
measure: Oxford score
timeFrame: 6mths and Annually post-surgery
measure: UCLA activity rating
timeFrame: 6mths and Annually post-surgery
measure: Thigh pain analysis
timeFrame: 6mths and Annually post-surgery
measure: Radiological analysis
timeFrame: pre-discharge, 6mths, 1yr, 2yrs, 3yrs, 5yrs, 7yrs, 10yrs and 15yrs post-surgery
Other outcomes:
Locations:
city: Shanghai
country: China
facility: 2. Ruijin Hospital
city: Pokfulam
country: Hong Kong
facility: 3. The University of Hong Kong at Queen Mary Hospital
city: Bergamo
country: Italy
facility: 1. Ospedale Riuniti Di Bergamo
city: Seoul
country: Korea, Republic of
facility: 4. Yonsei University College of Medicine
city: Auckland
country: New Zealand
facility: 5. Middlemore Hospital
Study officials:
References: