Back to resultsA Prospective Clinical Study On A Total Hip Resurfacing System
Primary Purpose
Arthritis, Avascular Necrosis
Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
ReCap Total Hip Resurfacing System
Sponsored by
About this trial
This is an interventional treatment trial for Arthritis
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
Sites / Locations
- Knowledge Center for Orthopedic Surgery, St. Anna hospital
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
ReCap
Arm Description
ReCap Total Hip Resurfacing System
Outcomes
Primary Outcome Measures
Harris Hip Score, Device Revision/Removal, Radiographic Evaluation
Secondary Outcome Measures
Complications
Full Information
NCT ID
NCT00603395
First Posted
December 23, 2007
Last Updated
May 15, 2014
Sponsor
St. Anna Ziekenhuis, Geldrop, Netherlands
1. Study Identification
Unique Protocol Identification Number
NCT00603395
Brief Title
A Prospective Clinical Study On A Total Hip Resurfacing System
Official Title
A Prospective Clinical Study On A Total Hip Resurfacing System
Study Type
Interventional
2. Study Status
Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
September 2004 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
May 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
St. Anna Ziekenhuis, Geldrop, Netherlands
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This prospective clinical study is to demonstrate the efficacy and safety of ReCap Total Hip Resurfacing System.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthritis, Avascular Necrosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
298 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ReCap
Arm Type
Other
Arm Description
ReCap Total Hip Resurfacing System
Intervention Type
Device
Intervention Name(s)
ReCap Total Hip Resurfacing System
Intervention Description
This is a hip resurfacing system.
Primary Outcome Measure Information:
Title
Harris Hip Score, Device Revision/Removal, Radiographic Evaluation
Time Frame
2 years postoperative
Secondary Outcome Measure Information:
Title
Complications
Time Frame
Anytime
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
H J Hoekstra, MD
Organizational Affiliation
St. Anna hospital, Geldrop
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
T Sybesma, PhD
Organizational Affiliation
St. Anna hospital, Geldrop
Official's Role
Principal Investigator
Facility Information:
Facility Name
Knowledge Center for Orthopedic Surgery, St. Anna hospital
City
Geldrop
Country
Netherlands
12. IPD Sharing Statement
Citations:
PubMed Identifier
23234268
Citation
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.
Results Reference
derived
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A Prospective Clinical Study On A Total Hip Resurfacing System
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