A Prospective Clinical Study On A Total Hip Resurfacing System

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Biomet, Inc.
ClinicalTrials.gov Identifier:
NCT00604734
First received: December 23, 2007
Last updated: December 4, 2013
Last verified: December 2013
  Purpose

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


Condition Intervention
Arthritis
Avascular Necrosis
Device: ReCap Total Hip Resurfacing System

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective Clinical Study On A Total Hip Resurfacing System

Further study details as provided by Biomet, Inc.:

Primary Outcome Measures:
  • Harris Hip Score, Device Revision/Removal, Radiographic Evaluation [ Time Frame: 2 years postoperative ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Complications [ Time Frame: Anytime ] [ Designated as safety issue: Yes ]

Enrollment: 280
Study Start Date: October 2004
Estimated Study Completion Date: October 2017
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
ReCap
ReCap Total Hip Resurfacing System
Device: ReCap Total Hip Resurfacing System
This is a hip resurfacing system.
Other Names:
  • Total hip resurfacing
  • ReCap

Detailed Description:

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.

Primary endpoints:

  • Total Harris hip score
  • Device revisions or removals

Secondary endpoints:

  • 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

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients with a preoperative Total Harris Hip Score of < 70
  2. Conservative treatment has proven unsuccessful
  3. Primary hip surgery
  4. Patients requiring hip resurfacing for degenerative joint disease (inflammatory or non- inflammatory) or any of the composite diagnoses of:

    1. Osteoarthritis
    2. Avascular necrosis
    3. Legg Perthes
    4. Rheumatoid Arthritis
    5. Juvenile Rheumatoid Arthritis
    6. Systemic Lupus Erythematosus
    7. Developmental Dysplasia, which does not prevent stable acetabular reconstruction
    8. Post traumatic arthritis S. Patients at least 18 years of age

6. Patients of all races and gender 7. Patients who are able to follow post-operative care instructions 8. Patients who are willing and able to return for scheduled follow-up evaluations 9. Patient has signed the IRB approved Informed Consent Form

Exclusion Criteria:

  1. Patients with a preoperative Total Harris Hip Score of > 70
  2. Previous prosthetic hip replacement device (including other surface arthroplasty, endoprosthesis,etc) in the operative hip
  3. Contralateral hip prosthesis (total hip replacement or surface replacement),including staged or simultaneous procedures
  4. Developmental dysplasla, which prevents stable acetabular reconstruction
  5. Patients with previous Girdlestone procedures
  6. Patients with above knee amputation of the contralateral and/or ipsilateral leg
  7. Severe osteoarthritis or marked bone loss,which would preclude proper fixation of the prosthetic device(s)
  8. Active or suspected systemic or localized Infection
  9. Parkinson's or Alzheimer's Disease
  10. Patients with severe instability or deformity of the ligaments and/or surrounding soft tissue,which would preclude stability of the prosthesis
  11. Patients less than 18 years of age
  12. Patients with condition(s) that may Interfere with the survival of the femoral resurfacing or acetabular replacements or their outcomes,including Paget's Disease, Charcot's Disease, Sickle Cell Anemia or traits Severe osteoporosis compromising bone stock (I.e.Dorr type C bone Lower extremity muscular atrophy Neuromuscular disease
  13. Patients with a clinical conditions that may limit follow-up,including: immunocompromised conditions, hepatitis, active tuberculosis, neoplastic disease, chronic renal failure, organ transplant recipients, known terminal disease process
  14. Patients with a "fused"hip
  15. Patients with metal allergy or hypersensitivity
  16. Participation in a study of any investigational product (drug or device) within the past 12 months
  17. Prisoners,known drug or alcohol abuser,or mentally incompetent individuals
  18. Systemic steroids within 6 months
  19. Patients with a known malignancy
  20. Patients who are pregnant
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00604734

Locations
Belgium
Az Nikolaas Campus Sint Niklaas
Sint Niklaas, Belgium
Sponsors and Collaborators
Biomet, Inc.
Investigators
Principal Investigator: H P Delport, MD AZ NIKOLAAS CAMPUS SINT NIKLAAS
Principal Investigator: Jo De Schepper, MD AZ NIKOLAAS CAMPUS SINT NIKLAAS
  More Information

No publications provided

Responsible Party: Biomet, Inc.
ClinicalTrials.gov Identifier: NCT00604734     History of Changes
Other Study ID Numbers: EU-8
Study First Received: December 23, 2007
Last Updated: December 4, 2013
Health Authority: Belgium: Ministry of Social Affairs, Public Health and the Environment

ClinicalTrials.gov processed this record on October 21, 2014