A Clinical Investigation of the M2a- 38™ Hip System

Osteoarthritis Clinical Trial

Official title:

M2a- 38™ Hip System Prospective Data Collection

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00698503
• Other study ID #: 12380-6
• Status: Terminated
• Phase: N/A
• First received: June 13, 2008
• Last updated: June 19, 2017
• Start date: January 2002
• Est. completion date: December 2008

Study information

• Verified date: June 2017
• Source: Zimmer Biomet
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this prospective clinical data collection is to document the performance and clinical outcomes of the M2a- 38™ Hip System

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 190
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients having primary cemented or cementless total hip replacement for non-inflammatory degenerative joint disease (NIDJD) or any of its composite diagnosis of osteoarthritis, avascular necrosis, traumatic arthritis, subcapital fracture, legg perthes, slipped capital epiphysis, fracture of the pelvis, diastrophic variant.

• Patients with full skeletal maturity

• Patients undergoing unilateral total hip arthroplasty or bilateral total hip arthroplasty, either staged or simultaneously

• Patients of all races and gender

• Patients who are able to follow postoperative care instructions

• Patients who are able and willing to return for follow-up evaluations

• Patients have preoperative total Harris Hip Score less than 70 with at least moderate pain.

Exclusion Criteria:

• Patients diagnosed with inflammatory degenerative arthritis (IDJD) to include the following composite diagnoses: rheumatoid arthritis, systemic lupus erythematous, pigmented villonodular synovitis, juvenile rheumatoid arthritis and other arthritic processes of inflammatory or autoimmune etiology.

• Patients less than 18 years.

• Patients with the presence of a previous prosthetic hip replacement device (any type, including surface replacement arthroplasty, endoprosthesis, etc.)in the hip joint to be operated.

• Patients with previous Girdlestone procedures.

• Patients with above the knee amputation of the contralateral and/or ipsilateral leg.

• Patients with osteoporosis, or marked bone loss which would preclude proper fixation of the prosthesis.

• Patients who are pregnant.

• Patients with an active or suspected infection in or around the hip.

• Patients with Parkinson's disease.

• Patients with vascular insufficiency, muscular atrophy, or neuromuscular disease in the affected limb.

• Patients with severe instability or deformity of the ligaments and/or surrounding soft tissue which would preclude stability of the prosthesis.

• Patients with a highly communicable disease or diseases that may limit follow-up (e.g. immuno-compromised conditions, hepatitis, active tuberculosis, neoplastic disease, etc.).

• Patients unwilling or unable to comply with a rehabilitation program for a cemented or cementless total hip replacement or who indicate difficulty or inability to return for follow-up visits prescribed by the study protocol.

• Patients with previous hip surgery or conditions that may interfere with the total hip replacement's survival or outcome, e.g., Paget's disease, Charcot's disease, severe osteoporosis compromising bone stock (Dorr type C bone).

• Patients who qualify for inclusion in the study, but refuse consent to participate in the study.

• Patients with a "fused" hip.

• Patients who have had a total hip arthroplasty on the contralateral hip within the last year.

Related Conditions & MeSH terms

• Avascular Necrosis
• Joint Diseases
• Necrosis
• Non-inflammatory Degenerative Joint Disease
• Osteoarthritis

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Biomet Orthopedics, LLC

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Harris Hip Score		12 weeks, 1 year, 3 years, 5 years
Secondary	Incidence of revisions and removals		Any time