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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03168750
Recruitment Status : Recruiting
First Posted : May 30, 2017
Last Update Posted : October 18, 2019
Sponsor:
Information provided by (Responsible Party):
Medacta USA

Brief Summary:
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 or disease Intervention/treatment Phase
Osteoarthritis, Hip Device: Femoral Component:Medacta Masterloc Stem and Medacta MPACT cup. Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: N/A
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: None (Open Label)
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
Actual Study Start Date : July 25, 2017
Estimated Primary Completion Date : August 1, 2028
Estimated Study Completion Date : December 1, 2028

Resource links provided by the National Library of Medicine


Arm 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.




Primary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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 :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 75 Years   (Child, Adult, Older Adult)
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

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): NCT03168750


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

Locations
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United States, Arizona
Tucson Othropedic Institute Recruiting
Oro Valley, Arizona, United States, 85755
Contact: John Maltry, MD    520-544-9700      
Principal Investigator: John Maltry, MD         
United States, Utah
Jordan Valley Medical Center of Orthopedics Rehabilitation and Excellence Recruiting
West Jordan, Utah, United States, 84088
Contact: Charles Marshall, MD         
United States, Washington
Spokane Joint Replacement Center Recruiting
Spokane, Washington, United States, 99218
Contact: David Scott, MD    509-466-6393    dfscott@orthospecialtyclinic.com   
Principal Investigator: David F Scott, MD         
Sponsors and Collaborators
Medacta USA
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Responsible Party: Medacta USA
ClinicalTrials.gov Identifier: NCT03168750    
Other Study ID Numbers: MUSA-H-ML-001
First Posted: May 30, 2017    Key Record Dates
Last Update Posted: October 18, 2019
Last Verified: March 2019

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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
Additional relevant MeSH terms:
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Osteoarthritis, Hip
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases