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

June 16, 2023 updated by: Medacta USA

Prospective, Multicenter Study to Assess Performance of a Tapered Porous Coated Stem and a Cementless Hemispherical Acetabular Component in Total Hip Arthroplasty

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Oro Valley, Arizona, United States, 85755
        • Tucson Othropedic Institute
    • Utah
      • West Jordan, Utah, United States, 84088
        • Jordan Valley Medical Center of Orthopedics Rehabilitation and Excellence
    • Washington
      • Spokane, Washington, United States, 99218
        • Spokane Joint Replacement Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 75 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Patients undergoing surgery as part of routine care.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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.
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
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.
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
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.
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
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.
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
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.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medacta USA

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 25, 2017

Primary Completion (Estimated)

March 1, 2024

Study Completion (Estimated)

May 1, 2024

Study Registration Dates

First Submitted

May 17, 2017

First Submitted That Met QC Criteria

May 25, 2017

First Posted (Actual)

May 30, 2017

Study Record Updates

Last Update Posted (Actual)

June 22, 2023

Last Update Submitted That Met QC Criteria

June 16, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MUSA-H-ML-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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