AL-2 MP-1 (Polyimide) Acetabular Liner

NCT02503891 | Unknown

• 1 other identifier: MA-01
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

M.M.A.TECH Ltd. product is an Acetabular Liner Family produced of an advanced polyimide - MP-1™. M.M.A.TECH Ltd. produces the Liners according to EN ISO 13485:2012 approved manufacturing process and supplies them to the customer. The aim of this study is to evaluate, in the frame of PMCF, the safety and performance of using AL-X MP1 Polyimide Acetabular liners in Total Hip Replacement surgery by clinical following up of patients for a period of 2 years .

Conditions

Osteoarthritis; Avascular Necrosis; Rheumatoid Arthritis; Congenital Dysplasia of the Hip; Ankylosing Spondylitis; Post-traumatic; Arthrosis; Injury of Hip

Outcome Measures

Primary Outcomes (2)

• Clinical patient status according to Harris Score

  \>60

  6 months

• Radiographic success

  o Radiographic success will be determined by femoral subsidence \< 2mm, acetabular migration \< 2mm, cup inclination \< 4°, no acetabular or femoral osteolysis, and acetabular and femoral lucencies less than 50% of visible porous coating

  3 mth , 12mth, 24 mth post-surgery

Study Arms (1)

Polymer on Ceramic

EXPERIMENTAL

MP-1 Polymer on Ceramic articulation system

Device: MP-1 Polymer on Ceramic Articulation system

Interventions

MP-1 Polymer on Ceramic Articulation system DEVICE

MP-1 Polymer liner on Ceramic head

Also known as: AL-2 MP-1 Polyimide Acetabular liner

Polymer on Ceramic

Eligibility Criteria

• Age: 21 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (Patient must meet all of the following characteristics to be enrolled in the study):
• Males and females, 21 to 90 years of age, inclusive;
• Primary diagnosis of non-inflammatory arthritis (osteoarthritis) or inflammatory arthritis (rheumatoid arthritis), or patients requiring a revision as specified previously;
• The patient or his/her legal guardian is willing to consent to participate in the study by signing and dating the approved consent form;
• The patient will be available for follow-up through at least two years postoperative;
• The patient has met an acceptable preoperative medical clearance and is free or treated for cardiac, pulmonary, hematological, etc., conditions that would pose excessive operative risk (FDA requirement);
• The patient has a total Harris Hip Score of less than or equal to 60 (FDA requirement);

You may not qualify if:

• with any of the following characteristics must be excluded from the study):
• Patients known to have insufficient quantity or quality of bone support resulting from Conditions such as cancer, femoral osteotomy, Girdlestone resection, significant osteoporosis or metabolic disorders of calcified tissues. Patients with physical conditions tending to place extreme loads on implants such as morbid obesity (\> 100 pounds over desirable body weight), Charcot joints, muscle deficiencies, or multiple joint disabilities;
• Patients with active localized or systemic infection;
• Patients who have not reached full skeletal maturity;
• Patient has had a total knee arthroplasty of either leg
• Patient psychological or neurological conditions which tend to preempt the patient's ability or willingness to restrict activities or follow medical advice, especially during the postoperative period, e.g.: drug or alcohol abuse, serious mental illness or retardation, or general neurological conditions;
• The patient is participating in any other pharmaceutical, biologic or medical device clinical investigation;
• Immunosuppressive disorders - immunosuppressive disorders are chronic conditions characterized by markedly inhibited ability to respond to antigenic stimuli. Examples of such conditions include patients who are on immunosuppressive therapy (corticosteroid hormones in large amounts, cytotoxic drugs, antilymphocytic serum or irradiation in large doses), patients receiving therapy to prevent homograft rejection, patients who have acquired immunodeficiency syndrome (AIDS), or auto-immune diseases (except rheumatoid arthritis).
• Pregnancy.
• Patients with known sensitivity to materials in the device.

Sponsors & Collaborators

• M.M.A Tech Ltd.: lead

Study Sites (1)

Rambam Hospital

Haifa, Israel

RECRUITING

MeSH Terms

Conditions

Osteoarthritis; Osteonecrosis; Arthritis, Rheumatoid; Hip Dislocation, Congenital; Spondylitis, Ankylosing; Hip Injuries

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Bone Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Developmental Dysplasia of the Hip; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Axial Spondyloarthritis; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Ankylosis; Wounds and Injuries

Study Officials

• Simha Sibony

  M.M.A Tech Ltd.

  STUDY CHAIR

Central Study Contacts

Simha Sibony

CONTACT

+972-52-654-6625; simha@mma-tech.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2015
• First Posted: July 21, 2015
• Study Start: September 15, 2017
• Primary Completion: September 1, 2018
• Study Completion: August 1, 2020
• Last Updated: December 20, 2017

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will share

Locations

IL (1)