A Clinical Investigation of the M2a- 38™ Hip System

NCT00698503 | Terminated

• 1 other identifier: 12380-6
• Study Type: observational
• Target: 190
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Non-inflammatory Degenerative Joint Disease; Osteoarthritis; Avascular Necrosis

Keywords

Metal on Metal; Total Hip Arthroplasty; Total Hip Replacement

Outcome Measures

Primary Outcomes (1)

• Harris Hip Score

  12 weeks, 1 year, 3 years, 5 years

Secondary Outcomes (1)

• Incidence of revisions and removals

  Any time

Study Arms (1)

M2a- 38™ Hip System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients that have already made the decision to undergo Total Hip Replacement and will receive the M2a- 38™ Hip System

You may qualify if:

• 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.

You may not qualify if:

• 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 with a "fused" hip.

Sponsors & Collaborators

• Biomet Orthopedics, LLC: lead

MeSH Terms

Conditions

Osteoarthritis; Osteonecrosis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Bone Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Kenneth J Beres, MD

  Director, Clinical Research, Biomet Orthopedics, LLC

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2008
• First Posted: June 17, 2008
• Study Start: January 1, 2002
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: June 21, 2017

Record last verified: 2017-06