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A Prospective Clinical Study On A Total Hip Resurfacing System

Primary Purpose

Arthritis, Avascular Necrosis

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
ReCap Total Hip Resurfacing System
Sponsored by
Zimmer Biomet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Arthritis

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Az Nikolaas Campus Sint Niklaas

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

First Posted
December 23, 2007
Last Updated
February 7, 2019
Sponsor
Zimmer Biomet
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1. Study Identification

Unique Protocol Identification Number
NCT00604734
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
February 2019
Overall Recruitment Status
Completed
Study Start Date
October 2004 (undefined)
Primary Completion Date
October 2007 (Actual)
Study Completion Date
October 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zimmer Biomet

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
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.
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

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
280 (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
Other Intervention Name(s)
Total hip resurfacing, ReCap
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: Patients with a preoperative Total Harris Hip Score of < 70 Conservative treatment has proven unsuccessful Primary hip surgery Patients requiring hip resurfacing for degenerative joint disease (inflammatory or non- inflammatory) or any of the composite diagnoses of: Osteoarthritis Avascular necrosis Legg Perthes Rheumatoid Arthritis Juvenile Rheumatoid Arthritis Systemic Lupus Erythematosus Developmental Dysplasia, which does not prevent stable acetabular reconstruction 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: Patients with a preoperative Total Harris Hip Score of > 70 Previous prosthetic hip replacement device (including other surface arthroplasty, endoprosthesis,etc) in the operative hip Contralateral hip prosthesis (total hip replacement or surface replacement),including staged or simultaneous procedures Developmental dysplasla, which prevents stable acetabular reconstruction Patients with previous Girdlestone procedures Patients with above knee amputation of the contralateral and/or ipsilateral leg Severe osteoarthritis or marked bone loss,which would preclude proper fixation of the prosthetic device(s) Active or suspected systemic or localized Infection Parkinson's or Alzheimer's Disease Patients with severe instability or deformity of the ligaments and/or surrounding soft tissue,which would preclude stability of the prosthesis Patients less than 18 years of age 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 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 Patients with a "fused"hip Patients with metal allergy or hypersensitivity Participation in a study of any investigational product (drug or device) within the past 12 months Prisoners,known drug or alcohol abuser,or mentally incompetent individuals Systemic steroids within 6 months Patients with a known malignancy Patients who are pregnant
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jo De Schepper, MD
Organizational Affiliation
AZ Nikolaas
Official's Role
Principal Investigator
Facility Information:
Facility Name
Az Nikolaas Campus Sint Niklaas
City
Sint Niklaas
Country
Belgium

12. IPD Sharing Statement

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A Prospective Clinical Study On A Total Hip Resurfacing System

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