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Trial record 10 of 128 for:    Recruiting, Not yet recruiting, Available Studies | "Hip Injuries"

AL-2 MP-1 (Polyimide) Acetabular Liner

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ClinicalTrials.gov Identifier: NCT02503891
Recruitment Status : Recruiting
First Posted : July 21, 2015
Last Update Posted : December 20, 2017
Sponsor:
Information provided by (Responsible Party):
M.M.A Tech Ltd.

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 .


Condition or disease Intervention/treatment Phase
Osteoarthritis Avascular Necrosis Rheumatoid Arthritis Congenital Dysplasia of the Hip Ankylosing Spondylitis Post-traumatic; Arthrosis Injury of Hip Device: MP-1 Polymer on Ceramic Articulation system Not Applicable

Detailed Description:

The procedure involves removal of the diseased parts of the joint, that is the damaged cartilage and adjacent bone, and replacing them with artificial parts which closely resemble in structure and/or function the removed native parts.

The artificial parts fit onto the reshaped bone and are fixed either with bone cement (e.g., polymethylmethacrylate) and press fit of the part(cemented), or by self-anchorage with bone ingrowth to its porous surface(cementless).

The design of the artificial parts may include a stem, a keel or pegs, which fit onto the medullary canal of the bone or into a hole pre-prepared in the bone. An artificial part may fit loosely and be fixed with bone cement, press-fit for self- anchorage or include extendible anchors which are retracted upon placement and extended thereafter so as to secure the implant in place.

Following fixation of the components, the joint is reduced and the soft tissue tension is appropriately checked to reassure stability of the joint.

The MP-1™ acetabular liner will be tapper locked in acetabular metal shells to resurface the acetabular socket in cementless total hip replacement.

MMaTech Ltd will manufacture the liners to perfectly fit into the external metallic shell of the following sizes (mm):

LINER CUP SIZE LINER SIZE HEAD Liner thickness AL-2MP132040 44-48 32 ID 40 OD 32 4 mm AL-2MP136044 50-54 36 ID 44 OD 36 4mm AL-2MP136048 56-66 36 ID 48 OD 36 6mm AL-2MP140048 56-66 40 ID 48 OD 40 4mm

The MP-1™ Acteabular liners are intended to be used only against ceramic femoral heads- Biolox Delta


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Total Hip Replacement - MP-1 Acetabular Liner
Actual Study Start Date : September 15, 2017
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Polymer on Ceramic
MP-1 Polymer on Ceramic articulation system
Device: MP-1 Polymer on Ceramic Articulation system
MP-1 Polymer liner on Ceramic head
Other Name: AL-2 MP-1 Polyimide Acetabular liner




Primary Outcome Measures :
  1. Clinical patient status according to Harris Score [ Time Frame: 6 months ]
    >60

  2. Radiographic success [ Time Frame: 3 mth , 12mth, 24 mth post-surgery ]
    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



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Ages Eligible for Study:   21 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

The inclusion criteria for subject participation in the study are:

(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);
  • The patient meets none of the exclusion criteria.

Exclusion Criteria:

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02503891


Contacts
Contact: Simha Sibony +972-52-654-6625 simha@mma-tech.com

Locations
Israel
Rambam Hospital Recruiting
Haifa, Israel
Contact: SIMHA SIBONY    +972-52-654-6625    simha@mma-tech.com   
Sponsors and Collaborators
M.M.A Tech Ltd.
Investigators
Study Chair: Simha Sibony M.M.A Tech Ltd.

Responsible Party: M.M.A Tech Ltd.
ClinicalTrials.gov Identifier: NCT02503891     History of Changes
Other Study ID Numbers: MA-01
First Posted: July 21, 2015    Key Record Dates
Last Update Posted: December 20, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: mmatech website

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Hip Injuries
Osteoarthritis
Arthritis, Rheumatoid
Spondylitis
Necrosis
Spondylitis, Ankylosing
Joint Diseases
Hip Dislocation, Congenital
Arthritis
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Bone Diseases, Infectious
Infection
Bone Diseases
Spinal Diseases
Pathologic Processes
Spondylarthropathies
Spondylarthritis
Ankylosis
Wounds and Injuries
Musculoskeletal Abnormalities
Congenital Abnormalities