AL-2 MP-1 (Polyimide) Acetabular Liner
NCT02503891 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50
Last updated 2017-12-20
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
Interventions
- DEVICE
-
MP-1 Polymer on Ceramic Articulation system
MP-1 Polymer liner on Ceramic head
Sponsors & Collaborators
-
M.M.A Tech Ltd.
lead INDUSTRY
Principal Investigators
-
Simha Sibony · M.M.A Tech Ltd.
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 21 Years
- Max Age
- 90 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2017-09-15
- Primary Completion
- 2018-09-30
- Completion
- 2020-08-31
Countries
- Israel
Study Locations
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