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

Study 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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	Yes
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	N/A - 75 Years
Gender	All

More Inclusion & Exclusion 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT03168750
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Medacta USA
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Osteoarthritis, Hip

Arms & Interventions

Arms

Other: 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.

Interventions

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Tucson Othropedic Institute, Oro Valley, Arizona

Status

Recruiting

Address

Tucson Othropedic Institute

Oro Valley, Arizona, 85755

Site Contact

John Maltry, MD

[email protected]

520-544-9700

West Jordan, Utah

Status