Arthritis Trial Finder
Analysis of a Tapered Porous Coated Stem and a Cementless Hemispherical Acetabular Component
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.
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
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.
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|Eligible Ages||N/A - 75 Years|
- - 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
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.
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.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Principal Investigator Affiliation||N/A|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
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Jordan Valley Medical Center of Orthopedics Rehabilitation and Excellence
West Jordan, Utah, 84088
Charles Marshall, MD
Tucson Othropedic Institute
Oro Valley, Arizona, 85755
John Maltry, MD
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