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Trial record 4 of 10 for:    MPACT

Analysis of a Tapered Porous Coated Stem and a Cementless Hemispherical Acetabular Component

This study is not yet open for participant recruitment.
See Contacts and Locations
Verified May 2017 by Medacta USA
Sponsor:
Information provided by (Responsible Party):
Medacta USA
ClinicalTrials.gov Identifier:
NCT03168750
First received: May 17, 2017
Last updated: June 28, 2017
Last verified: May 2017
  Purpose
This prospective study will evaluate the hip function and quality of life of patients operated for total hip arthroplasty with Masterloc femoral stem and MPACT acetabular cup. The results of this study will establish the performance of Masterloc femoral component (Medacta International SA) and MPACT acetabular component (Medacta International SA), and provide a general estimate of survivorship, clinical effectiveness and complications.

Condition Intervention
Osteoarthritis, Hip Device: Femoral Component:Medacta Masterloc Stem and Medacta MPACT cup.

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Intervention Model Description:
Masterloc femoral component (K151531) and MPACT acetabular shell (K103721, K132879, K122641, K143453, K143453, K131458) with Highcross PE liner.
Masking: No masking
Primary Purpose: Treatment
Official Title: Prospective, Multicenter Study to Assess Performance of a Tapered Porous Coated Stem and a Cementless Hemispherical Acetabular Component in Total Hip Arthroplasty

Further study details as provided by Medacta USA:

Primary Outcome Measures:
  • Harris Hip Score (HHS) [ Time Frame: pre-operative, 4-8 weeks post-operative, 4-8 months post-operative, 9-15 months post operative, 18-30 months post-operative, 4-6 years post-operative, 9-11 years post-operative. ]
    Assessment of the improvement of clinical outcomes following total hip replacement using the Harris Hip Score

  • Hip Disability and Osteoarthritis Outcome Score (HOOS) [ Time Frame: pre-operative, 4-8 weeks post-operative, 4-8 months post-operative, 9-15 months post operative, 18-30 months post-operative, 4-6 years post-operative, 9-11 years post-operative. ]
    Assessment of the improvement in activity levels following total hip replacement using the Hip Disability and Osteoarthritis Outcome Score

  • Oxford Hip Score (OHS) [ Time Frame: pre-operative, 4-8 weeks post-operative, 4-8 months post-operative, 9-15 months post operative, 18-30 months post-operative, 4-6 years post-operative, 9-11 years post-operative. ]
    Assessment of the improvement in the patients physical level of activity using the Oxford Hip Score

  • Veterans Rand 12 (VR-12) [ Time Frame: pre-operative, 4-8 weeks post-operative, 4-8 months post-operative, 9-15 months post operative, 18-30 months post-operative, 4-6 years post-operative, 9-11 years post-operative. ]
    Assessment of the improvement in your health using the Veterans Rand 12

  • EuroQol 5 dimension (EQ-5D) [ Time Frame: pre-operative, 4-8 weeks post-operative, 4-8 months post-operative, 9-15 months post operative, 18-30 months post-operative, 4-6 years post-operative, 9-11 years post-operative. ]
    Assessment of the improvement in quality of life and joint movement using the EQ-5D


Secondary Outcome Measures:
  • Radiographic analysis [ Time Frame: pre-operative, 4-8 weeks post-operative, 4-8 months post-operative, 9-15 months post operative, 18-30 months post-operative, 4-6 years post-operative, 9-11 years post-operative. ]
    Radiographic analysis will include evaluation of osteolysis, radiolucent lines, bone hypertrophy, component migration, heterotopic ossification, resorption of calcar.


Estimated Enrollment: 300
Anticipated Study Start Date: August 1, 2017
Estimated Study Completion Date: December 1, 2028
Estimated Primary Completion Date: August 1, 2028 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Femoral Component:Medacta Masterloc Stem and Medacta MPACT cup
All patients enrolled will receive the Medacta Masterloc Stem and MPACT cup with Highcross PE liner.
Device: Femoral Component:Medacta Masterloc Stem and Medacta MPACT cup.
Total hip arthroplasty (THA) is one of the most commonly performed and successful orthopaedic operations in improving a patient's quality of life. Orthopaedic surgeons are continually striving to improve all aspects of care relating to this procedure whether this is improvements in implant technology, instrument improvement, or the technique involved in performing the procedure.The results of this study will establish the performance of the femoral component and acetabular component, and provide a general estimate of survivorship, clinical effectiveness and complications.

  Eligibility

Ages Eligible for Study:   up to 75 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Primary osteoarthritis of the hip necessitating primary hip replacement,
  • Suitability for straight cementless stem,
  • Adult male and female under 75 years old,
  • Ability to give informed consent ,
  • Patients who understand the conditions of the study and are willing to participate for the length of the prescribed follow-up.

Exclusion Criteria:

  • Off-label use of the Medacta Masterloc femoral component and MPACT acetabular component
  • Post-traumatic deformity in the affected hip,
  • Patient suffering from Inflammatory arthritis including rheumatoid arthritis,
  • Patient suffering by congenital or developmental deformity,
  • Severe osteoporosis,
  • History of surgery in the affected hip,
  • Perioperative fracture,
  • Personality disorders (dementia, alcohol or drug abuse etc) suspected of making completion of the trial uncertain,
  • Patients with a history of active infection
  • Pregnant women or those seeking to become pregnant
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03168750

Contacts
Contact: Mukesh Ahuja, MBBS, MS 312-548-3368 mahuja@medacta.us.com

Sponsors and Collaborators
Medacta USA
  More Information

Responsible Party: Medacta USA
ClinicalTrials.gov Identifier: NCT03168750     History of Changes
Other Study ID Numbers: MUSA-H-ML-001
Study First Received: May 17, 2017
Last Updated: June 28, 2017

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:
Osteoarthritis
Osteoarthritis, Hip
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on July 21, 2017