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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00208390




Registration number
NCT00208390
Ethics application status
Date submitted
13/09/2005
Date registered
21/09/2005
Date last updated
4/08/2016

Titles & IDs
Public title
A Multi-centre Study to Assess the Long-term Performance of the Summit™ Hip in Primary Total Hip Replacement
Scientific title
Prospective, Uncontrolled, Multi-Centre, Post-Marketing Surveillance Study to Evaluate the Long-Term Performance of Summit Tapered Hip in Cementless Total Hip Arthroplasty
Secondary ID [1] 0 0
CT01/25
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Rheumatoid Arthritis 0 0
Osteoarthritis 0 0
Post-traumatic Arthritis 0 0
Collagen Disorders 0 0
Avascular Necrosis 0 0
Traumatic Femoral Fractures 0 0
Nonunion of Femoral Fractures 0 0
Congenital Hip Dysplasia 0 0
Slipped Capital Femoral Epiphysis 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoarthritis
Inflammatory and Immune System 0 0 0 0
Rheumatoid arthritis
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders
Skin 0 0 0 0
Other skin conditions
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above
Injuries and Accidents 0 0 0 0
Fractures

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Summit Tapered Hip System

Other: Summit Tapered Hip System - A cementless, tapered femoral component for use in total hip replacement


Treatment: Devices: Summit Tapered Hip System
A cementless, tapered femoral component for use in total hip replacement
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Kaplan-Meier survivorship calculated at the five-year time point
Timepoint [1] 0 0
5yrs post-surgery
Secondary outcome [1] 0 0
Kaplan-Meier survivorship calculations
Timepoint [1] 0 0
Annually
Secondary outcome [2] 0 0
Harris Hip score
Timepoint [2] 0 0
6mths, 1yr, 2yrs, 3yrs, 5yrs, 7yrs, 10yrs and 15yrs post-surgery
Secondary outcome [3] 0 0
Oxford score
Timepoint [3] 0 0
6mths and Annually post-surgery
Secondary outcome [4] 0 0
UCLA activity rating
Timepoint [4] 0 0
6mths and Annually post-surgery
Secondary outcome [5] 0 0
Thigh pain analysis
Timepoint [5] 0 0
6mths and Annually post-surgery
Secondary outcome [6] 0 0
Radiological analysis
Timepoint [6] 0 0
pre-discharge, 6mths, 1yr, 2yrs, 3yrs, 5yrs, 7yrs, 10yrs and 15yrs post-surgery

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/02/2003
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/05/2012
Sample size
Target
Accrual to date
Final
275
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
China
State/province [1] 0 0
Shanghai
Country [2] 0 0
Hong Kong
State/province [2] 0 0
Pokfulam
Country [3] 0 0
Italy
State/province [3] 0 0
Bergamo
Country [4] 0 0
Korea, Republic of
State/province [4] 0 0
Seoul
Country [5] 0 0
New Zealand
State/province [5] 0 0
Auckland

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
DePuy International
Address
Country

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/study/NCT00208390
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00208390