A Prospective Clinical Study On A Total Hip Resurfacing System

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

Study Overview

• Status: Completed
• Conditions: Arthritis; Avascular Necrosis
• Intervention / Treatment: Device: 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

• Study Type: Interventional
• Enrollment (Actual): 280
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Sint Niklaas, Belgium
    • Az Nikolaas Campus Sint Niklaas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: ReCap; ReCap Total Hip Resurfacing System	Device: ReCap Total Hip Resurfacing System; This is a hip resurfacing system.; Other Names: Total hip resurfacing; ReCap

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Harris Hip Score, Device Revision/Removal, Radiographic Evaluation	2 years postoperative

Secondary Outcome Measures

Outcome Measure	Time Frame
Complications	Anytime

Collaborators and Investigators

• Sponsor: Zimmer Biomet
• Investigators: Principal Investigator: Jo De Schepper, MD, AZ Nikolaas

Study record dates

Study Major Dates

• Study Start: October 1, 2004
• Primary Completion (Actual): October 1, 2007
• Study Completion (Actual): October 1, 2012

Study Registration Dates

• First Submitted: December 23, 2007
• First Submitted That Met QC Criteria: January 29, 2008
• First Posted (Estimate): January 30, 2008

Study Record Updates

• Last Update Posted (Actual): February 11, 2019
• Last Update Submitted That Met QC Criteria: February 7, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Necrosis
• Other Study ID Numbers: EU-8

Drug and device information, study documents

• 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