A Prospective Clinical Study On A Total Hip Resurfacing System
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|ClinicalTrials.gov Identifier: NCT00604734|
Recruitment Status : Unknown
Verified January 2016 by Zimmer Biomet.
Recruitment status was: Active, not recruiting
First Posted : January 30, 2008
Last Update Posted : January 11, 2016
|Condition or disease||Intervention/treatment||Phase|
|Arthritis Avascular Necrosis||Device: ReCap Total Hip Resurfacing System||Not Applicable|
The study is designed as a prospective, multi-center, non-randomized study. It is designed to evaluate the effects of metal-on-metal acetabular articulating bearing surfaces.
The device will be used in conjunction with a cemented metal femoral resurfacing prosthesis.
The objective of this clinical investigation is to evaluate the safety and effectiveness of the metal-on-metal Recap Total Resurfacing System.
Performance will be assessed trough Harris Hip Score, radiographic evaluation at various postoperative visits. Adverse events and revisions will be documented for safety assessments.
- Total Harris hip score
- Device revisions or removals
- Total Harris hip score
- Radiographic changes as evidenced by:
I. Acetabular component migration, change in angle of inclination or presence of osteolysis II. Femoral component subsidence, femoral neck Fracture or presence of osteolysis
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||280 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Prospective Clinical Study On A Total Hip Resurfacing System|
|Study Start Date :||October 2004|
|Actual Primary Completion Date :||October 2007|
|Estimated Study Completion Date :||October 2017|
ReCap Total Hip Resurfacing System
Device: ReCap Total Hip Resurfacing System
This is a hip resurfacing system.
- Harris Hip Score, Device Revision/Removal, Radiographic Evaluation [ Time Frame: 2 years postoperative ]
- Complications [ Time Frame: Anytime ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00604734
|Az Nikolaas Campus Sint Niklaas|
|Sint Niklaas, Belgium|
|Principal Investigator:||Jo De Schepper, MD||AZ Nikolaas|