A Prospective Clinical Study On A Total Hip Resurfacing System

• Sponsor: Zimmer Biomet (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00604734
• Collaborator: (none)
• Enrollment: 280
• Location: 1
• Arm: 1
• Duration (Months): 96
• Patients Per Site Per Month: 2.9

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Arthritis; Avascular Necrosis	Device: ReCap Total Hip Resurfacing System	N/A

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:

1. Acetabular component migration, change in angle of inclination or presence of osteolysis

1. Femoral component subsidence, femoral neck Fracture or presence of osteolysis

Study Design

• Study Type: Interventional
• Actual Enrollment: 280 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Prospective Clinical Study On A Total Hip Resurfacing System
• Study Start Date: Oct 1, 2004
• Actual Primary Completion Date: Oct 1, 2007
• Actual Study Completion Date: Oct 1, 2012

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Harris Hip Score, Device Revision/Removal, Radiographic Evaluation [2 years postoperative]

Secondary Outcome Measures

1. Complications [Anytime]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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:

5. Osteoarthritis

6. Avascular necrosis

7. Legg Perthes

8. Rheumatoid Arthritis

9. Juvenile Rheumatoid Arthritis

10. Systemic Lupus Erythematosus

11. Developmental Dysplasia, which does not prevent stable acetabular reconstruction

12. Post traumatic arthritis S. Patients at least 18 years of age

13. 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

Locations

	Site	City	State	Country	Postal Code
1	Az Nikolaas Campus Sint Niklaas	Sint Niklaas		Belgium

Sponsors and Collaborators

• Zimmer Biomet

Investigators

• Principal Investigator: Jo De Schepper, MD, AZ Nikolaas

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Zimmer Biomet
• ClinicalTrials.gov Identifier: NCT00604734
• Other Study ID Numbers: EU-8
• First Posted: Jan 30, 2008
• Last Update Posted: Feb 11, 2019
• Last Verified: Feb 1, 2019

• 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
• Additional relevant MeSH terms: Necrosis

Study Results

No Results Posted as of Feb 11, 2019