Prospective Study on ReCap Versus Bonemaster Coated Cenos
Information source: Biomet, Inc.
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Osteoarthritis
Intervention: CENOS Hip stem with BoneMaster coating (Device); ReCap Total Hip Resurfacing System (Device)
Phase: N/A
Status: Recruiting
Sponsored by: Biomet, Inc. Official(s) and/or principal investigator(s):
Joachim Schmidt, MD, Principal Investigator, Affiliation: Dreifaltigkeits hospital
Summary
The aim of this comparative study is to evaluate the functional power of patients treated
with surface cap prostheses versus hip stems. The study will provide quantitative data of
functional power regain and will aid estimation of timing of return to work.
Clinical Details
Official title: Functional Capacity After Hip Joint Replacement. Evaluation of ReCap Surface Replacement and Cementless CENOS BoneMaster Prosthesis in Conjunction With PPF Screw Cup According to Bösch
Study design: Treatment, Non-Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: WOMAC score, Harris hip score, Oxford hip score, UCLA score, SF-12 score
Detailed description:
Two groups of patients (30 subjects each) will be analyzed concerning their functional
capacity before and after operation. Both groups will be prospectively controlled
intervention samples. Two age related control groups will be compared in a matched pair
design based on gender, body height, body mass, body mass index and functional fitness. Both
intervention groups will be measured prior to the operative intervention, 10 to 14 days as
well as 6 and 12 weeks after the operation. The functional capacity tests are related to
established tests. Nine activities of daily living were selected for kinematic, videographic,
ROM, force, reaction time, body reaction forces and centre of pressure evaluation.
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Within the approved indications for uses/intended uses of the device to be implanted.
- No existing joint replacement of the lower limbs
- No additional diseases of the lower limbs causing pain or restricting motion.
Exclusion Criteria:
- Violation of one of the inclusion criteria
Locations and Contacts
Dreifaltigkeits hospital, Cologne, Germany; Recruiting
Joachim Schmidt, MD, Phone: 0221 94071
Additional Information
Starting date: July 2006
Ending date: January 2009
Last updated: September 26, 2008
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