Clinical Trials Logo
  1. Home
  2. Arthritis
  3. NCT00603395
  4. Details
NCT00603395 Clinical Trial

A Prospective Clinical Study On A Total Hip Resurfacing System

Arthritis Clinical Trial

Official title:
A Prospective Clinical Study On A Total Hip Resurfacing System

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00603395
Other study ID # EU-6
Secondary ID
Status Completed
Phase N/A
First received December 23, 2007
Last updated May 15, 2014
Start date September 2004
Est. completion date May 2014

Study information
Verified date May 2014
Source St. Anna Ziekenhuis, Geldrop, Netherlands
Contact n/a
Is FDA regulated No
Health authority Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Study type Interventional

Clinical Trial Summary

This prospective clinical study is to demonstrate the efficacy and safety of ReCap Total Hip Resurfacing System.

Recruitment information / eligibility
Status Completed
Enrollment 298
Est. completion date May 2014
Est. primary completion date September 2012
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility 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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Device:
• ReCap Total Hip Resurfacing System
This is a hip resurfacing system.

Locations
Country Name City State
Netherlands Knowledge Center for Orthopedic Surgery, St. Anna hospital Geldrop

Sponsors (1)
Lead Sponsor Collaborator
St. Anna Ziekenhuis, Geldrop, Netherlands

Country where clinical trial is conducted

Netherlands, 

Outcome
Type Measure Description Time frame Safety issue
Primary Harris Hip Score, Device Revision/Removal, Radiographic Evaluation 2 years postoperative Yes
Secondary Complications Anytime Yes
See also
  Status Clinical Trial Phase
Completed NCT04228458 - ThermRheum Version 1 N/A
Withdrawn NCT04976972 - A Comparison of Patients Receiving a Total Knee Replacement With Robotic Assistance or With Conventional Instrumentation N/A
Completed NCT04037436 - Functional Exercise and Nutrition Education Program for Older Adults N/A
Completed NCT00069342 - Health Beliefs and Health Behaviors Among Minorities With Rheumatic Diseases
Completed NCT02944448 - A Study Evaluating Pain Relief and Safety of Orally Administered CR845 in Patients With Osteoarthritis of Hip or Knee Phase 2
Recruiting NCT02498808 - Interferon-lambda: Novel Biologics for Controlling Neutrophil-mediated Pathology in Rheumatic Diseases? N/A
Recruiting NCT02777060 - Exploring the Effectiveness of Sensor-based Balance Training on Patient Outcome Measures N/A
Enrolling by invitation NCT02487888 - A Study of the Impact of Genetic Testing on Clinical Decision Making and Patient Care N/A
Withdrawn NCT02136251 - Total Shoulder Replacement Outcomes With Autologous Bone Graft as Fixator for Glenoid Anchor Peg.
Completed NCT02143206 - Modifying Exercise for the COPD Patient
Completed NCT01407874 - A Randomized, Double-Blind, Dose-Response Study of the Safety and Uric Acid Effects of Oral Ulodesine Added to Allopurinol in Subjects With Gout and Concomitant Moderate Renal Insufficiency Phase 2
Completed NCT01285843 - Periprosthetic Bone Mineral Density After Total Hip Arthroplasty Performed Through a Minimally Invasive Anterior Approach (AMIS) With Either an AMIStem or a Quadra Femoral Component N/A
Completed NCT01172327 - Self-Directed Exercise Program for Adults With Arthritis N/A
Completed NCT00987870 - Safety and Efficacy of BFH772 in Psoriasis Patients Phase 1/Phase 2
Completed NCT00750984 - A Comparison of Two Different Surgical Techniques for Total Hip Resurfacing N/A
Completed NCT01184924 - Evaluation of the Arthritis Foundation Tai Chi Program N/A
Active, not recruiting NCT00611585 - A Safety and Efficacy Study of the Birmingham Hip Resurfacing System N/A
Completed NCT00379184 - Sensitization in Osteoarthritic Knees N/A
Completed NCT00403676 - Nursing Consultation in Out-patient Clinics for Patients With Inflammatory Rheumatic Disease N/A
Completed NCT00175448 - Comparison of Physiotherapy Versus Home Exercise Following Hip Replacement Surgery N/A