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

NCT ID: NCT03168750

Last Updated: 2024-11-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-07-25

Study Completion Date

2024-11-13

Brief Summary

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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.

Detailed Description

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Conditions

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Osteoarthritis, Hip

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Femoral Component:Medacta Masterloc Stem and Medacta MPACT cup.

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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
Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Medacta USA

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Tucson Othropedic Institute

Oro Valley, Arizona, United States

Site Status

Jordan Valley Medical Center of Orthopedics Rehabilitation and Excellence

West Jordan, Utah, United States

Site Status

Spokane Joint Replacement Center

Spokane, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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MUSA-H-ML-001

Identifier Type: -

Identifier Source: org_study_id

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