A Prospective Clinical Study On A Total Hip Resurfacing S... | NCT00603395

Studies
A Prospective Clinical Study On A Total Hip Resurfacing System

NCT00603395

Sponsor

St. Anna Ziekenhuis, Geldrop, Netherlands

Status

Completed

Last Update Posted

May 16, 2014Estimated

Enrollment

298Actual

Phase

Not Applicable

Conditions

Arthritis
Avascular Necrosis

Interventions

ReCap Total Hip Resurfacing System

Countries

Netherlands

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

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2004

Primary Completion Date

Sep 2012Actual

Completion Date

May 2014Actual

First Submitted Date

Dec 23, 2007

First Submission Date that Met QC Criteria

Jan 16, 2008

First Posted Date

Jan 29, 2008Estimated

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

May 15, 2014

Last Update Posted Date

May 16, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Walter van der Weegen, Researcher, St. Anna Ziekenhuis, Geldrop, NetherlandsPrincipal Investigator

Lead Sponsor

St. Anna Ziekenhuis, Geldrop, NetherlandsOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

298Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ReCap	Other	ReCap Total Hip Resurfacing System	Device: ReCap Total Hip Resurfacing System

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ReCap Total Hip Resurfacing System	Device	This is a hip resurfacing system.	ReCap

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Harris Hip Score, Device Revision/Removal, Radiographic Evaluation		2 years postoperative

Secondary Outcomes

Measure	Description	Time Frame
Complications		Anytime

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

intended for skeletally mature individuals undergoing primary surgery as a result of hip degenerative joint disease, or any composite diagnoses, including:
- Osteoarthritis
- Avascular necrosis
- Traumatic arthritis
- Legg Perthes
- Rheumatoid arthritis

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
H J Hoekstra, MD	St. Anna hospital, Geldrop	Principal Investigator
T Sybesma, PhD	St. Anna hospital, Geldrop	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Knowledge Center for Orthopedic Surgery, St. Anna hospital		Geldrop			Netherlands

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
23234268	Derived	van der Weegen W, Hoekstra HJ, Sijbesma T, Austen S, Poolman RW. Hip resurfacing in a district general hospital: 6-year clinical results using the ReCap hip resurfacing system. BMC Musculoskelet Disord. 2012 Dec 13;13:247. doi: 10.1186/1471-2474-13-247.

ID	Term
D001168	Arthritis
D010020	Osteonecrosis

ID	Term
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D001847	Bone Diseases
D009336	Necrosis