A Randomised Multi-centre Study to Compare the Long-term... | NCT00208468

Studies
A Randomised Multi-centre Study to Compare the Long-term Performance of the Future Hip to 3 Other Implants in Primary Total Hip Replacement

NCT00208468

Sponsor

DePuy International

Status

Terminated

Last Update Posted

Oct 7, 2016Estimated

Enrollment

317Actual

Phase

Phase 3

Conditions

Osteoarthritis
Post-traumatic Arthritis
Collagen Disorders
Avascular Necrosis
Traumatic Femoral Fractures
Nonunion of Femoral Fractures
Congenital Hip Dysplasia
Slipped Capital Femoral Epiphysis
Perthes Disease

Interventions

European Hip
Zweymüller
CLS Spotorno

Countries

Austria
Germany
Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Oct 2016

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Slow recruitment, investigators not wishing to continue with randomisation and a decision to rationalise this product from the Sponsors portfolio.

Expanded Access Info

Start Date

Feb 2000

Primary Completion Date

Jun 2005Actual

Completion Date

Mar 2015Actual

First Submitted Date

Sep 13, 2005

First Submission Date that Met QC Criteria

Sep 13, 2005

First Posted Date

Sep 21, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 6, 2016

Last Update Posted Date

Oct 7, 2016Estimated

Description Module

Brief Summary

This post-market clinical follow-up study was designed to compare hip replacement outcomes of the European Hip against 3 controls (Omniflex, Zweymuller, and Spotorno), however Omniflex did not end up being used. The first patient had surgery on February 18, 2000 and the final patient had surgery on September 2, 2005. There were 317 subjects consented but only 301 had hip replacement surgery (subjects received: 220 European hips, 33 Zweymuller, and 48 Spotorno). The study took place at three sites. Each site used their standard device as the control. The Austrian site enrolled 69 European hips and 33 Zweymuller hips. 92 European hips and 48 Spotorno hips were enrolled in Germany. Finally, the site in Italy enrolled 59 European hips. Although the study protocol intended collecting DEXA and RSA outcomes, the data collected by the sites did not include these outcomes.

Detailed Description

Not provided

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
European Hip	Other	A cementless femoral component for use in total hip replacement	Device: European Hip
Zweymüller	Active Comparator	A cementless femoral component for use in total hip replacement	Device: Zweymüller
CLS Spotorno	Active Comparator	A cementless femoral component for use in total hip replacement	Device: CLS Spotorno

Interventions

Name	Type	Description	Arm Group Labels	Other Names
European Hip	Device	A cementless femoral component for use in total hip replacement	European Hip

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To Compare Survivorship estimates between subjects receiving the European, Spotorno, and Zweymuller hip devices through the 2 year follow-up period.	Kaplan Meier survivorship analysis estimates the proportion of a population that will survive past a certain time avoiding a certain event. In this study, the event is removal of any component for any reason, also known as revision for any reason.	2yrs post-surgery

Secondary Outcomes

Measure	Description	Time Frame
Implant survivorship at 5 and 10 years.	This post market study was terminated early; therefore the 5 and 10 year data was not collected.	5 & 10 year post-op
To Compare Harris Hip Scores between subjects receiving the European, Spotorno, and Zweymuller hip devices.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

i) Administrative - The subject is able to understand the study, is willing to give voluntary, written, informed consent, will co-operate with assessment procedures and is geographically able to comply with the post-operative follow-up regime.

ii) Age - The subject's age is between 18 and 75 years inclusive.

iii) Sex - Male or female subjects may be recruited to the study.

iv) Diagnosis -Subjects must be undergoing primary THR surgery for non-inflammatory degenerative joint disease including osteoarthritis, avascular necrosis, post-traumatic arthritis, fractured neck of femur and non-union of fractured neck of femur, SUFE or Perthes disease.

v) Suitability - Subjects who in the opinion of the Investigator are considered to be suitable for treatment with the devices involved in the study.

Exclusion Criteria:

i) Subjects undergoing revision procedure to the operative hip.

ii) Subjects who have had a previous femoral osteotomy to the operative hip.

iii) Subjects who have a history of active sepsis in the joint.

iv) Subjects who have been diagnosed with primary or secondary carcinomas in the last five years (excluding basal cell carcinoma or cervical carcinoma).

v) Subjects with any condition which may, in the opinion of the Investigator, interfere with the total hip replacement's survival or outcome, e.g. Paget's disease, Charcot's disease.

vi) Subjects with psycho-social disorders which, in the opinion of the Investigator would limit rehabilitation.

vii) Subject's whose weight is > 100kg.

viii) Subjects with femoral head necrosis on the non-operated side (RSA and DEXA subjects only).

ix) Subjects who have a fracture of the femur > 6 months old (RSA and DEXA subjects only).

x) Subjects diagnosed as having ankylosing spondylitis (RSA and DEXA subjects only)

xi) Subjects with a known history of poor compliance to medical treatment.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

55 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Univ. Kliniken		Graz			Austria
Univesitätsklinikum Jena

ID	Term
D010003	Osteoarthritis
D003095	Collagen Diseases
D010020	Osteonecrosis
D006618	Hip Dislocation, Congenital
D060048	Slipped Capital Femoral Epiphyses
D007873	Legg-Calve-Perthes Disease

ID	Term
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases
D003240	Connective Tissue Diseases
D017437	Skin and Connective Tissue Diseases
D001847	Bone Diseases
D009336	Necrosis
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D000082602	Developmental Dysplasia of the Hip
D009139	Musculoskeletal Abnormalities
D000013	Congenital Abnormalities
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities
D010009	Osteochondrodysplasias
D001848	Bone Diseases, Developmental
D004839	Epiphyses, Slipped
D005271	Femur Head Necrosis