AL-2 MP-1 (Polyimide) Acetabular Liner

Total Hip Replacement - MP-1 Acetabular Liner

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 .

Study Overview

• Status: Unknown
• Conditions: Osteoarthritis; Rheumatoid Arthritis; Avascular Necrosis; Ankylosing Spondylitis; Post-traumatic; Arthrosis; Congenital Dysplasia of the Hip; Injury of Hip
• Intervention / Treatment: Device: MP-1 Polymer on Ceramic Articulation system

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
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Haifa, Israel
    • Recruiting
    • Rambam Hospital
    • Contact: SIMHA SIBONY; Phone Number: +972-52-654-6625; Email: simha@mma-tech.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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 Names: AL-2 MP-1 Polyimide Acetabular liner

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: M.M.A Tech Ltd.
• Investigators: Study Chair: Simha Sibony, M.M.A Tech Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2017
• Primary Completion (Anticipated): September 1, 2018
• Study Completion (Anticipated): August 1, 2020

Study Registration Dates

• First Submitted: July 14, 2015
• First Submitted That Met QC Criteria: July 18, 2015
• First Posted (Estimate): July 21, 2015

Study Record Updates

• Last Update Posted (Actual): December 20, 2017
• Last Update Submitted That Met QC Criteria: December 18, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Congenital Abnormalities; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Spinal Diseases; Bone Diseases; Spondylarthropathies; Spondylarthritis; Musculoskeletal Abnormalities; Joint Dislocations; Hip Dislocation; Bone Diseases, Infectious; Ankylosis; Osteoarthritis; Necrosis; Developmental Dysplasia of the Hip; Hip Dislocation, Congenital; Spondylitis; Spondylitis, Ankylosing
• Other Study ID Numbers: MA-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: mmatech website

Drug and device information, study documents

• 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