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: NCT00604734
• Other study ID #: EU-8
• Status: Completed
• Phase: N/A
• Start date: October 2004
• Est. completion date: October 2012

Study information

• Verified date: February 2019
• Source: Zimmer Biomet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 280
• Est. completion date: October 2012
• Est. primary completion date: October 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Avascular Necrosis
• Necrosis

Intervention

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

Locations

Country	Name	City	State
Belgium	Az Nikolaas Campus Sint Niklaas	Sint Niklaas

Sponsors (1)

Lead Sponsor	Collaborator
Zimmer Biomet

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Harris Hip Score, Device Revision/Removal, Radiographic Evaluation		2 years postoperative
Secondary	Complications		Anytime