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Orthopedic Implant
Hip Replacement Implants for Osteoarthritis
N/A
Waitlist Available
Research Sponsored by Medacta USA
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Primary osteoarthritis of the hip necessitating primary hip replacement
Adult male and female under 75 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 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.
Awards & highlights
Study Summary
This trial will study the hip function and quality of life of patients who had surgery to replace their hip with a Medacta International SA Masterloc femoral stem and MPACT acetabular cup.
Who is the study for?
This trial is for adults under 75 with primary osteoarthritis of the hip needing a replacement, who can consent and commit to follow-up. It excludes those with prior hip surgery, pregnancy or plans to become pregnant, severe osteoporosis, post-traumatic or congenital deformities in the hip, active infections, inflammatory arthritis like rheumatoid arthritis, or personality disorders.Check my eligibility
What is being tested?
The study tests how well patients do after getting a Masterloc femoral stem and MPACT acetabular cup implant in their hips. It looks at hip function and quality of life post-surgery to assess these implants' performance and long-term success rate.See study design
What are the potential side effects?
While not specified here, typical side effects from similar surgeries may include pain at the site of surgery, swelling around the hip area, risk of infection at the incision site or inside joint space; there's also a small chance of dislocation or loosening over time.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I need a hip replacement due to severe arthritis.
Select...
I am under 75 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 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.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~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.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
EuroQol 5 dimension (EQ-5D)
Harris Hip Score (HHS)
Hip Disability and Osteoarthritis Outcome Score (HOOS)
+2 moreSecondary outcome measures
Radiographic analysis
Trial Design
1Treatment groups
Experimental Treatment
Group I: Femoral Component:Medacta Masterloc Stem and Medacta MPACT cupExperimental Treatment1 Intervention
All patients enrolled will receive the Medacta Masterloc Stem and MPACT cup with Highcross PE liner.
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Who is running the clinical trial?
Medacta USALead Sponsor
16 Previous Clinical Trials
1,960 Total Patients Enrolled
10 Trials studying Osteoarthritis
949 Patients Enrolled for Osteoarthritis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a history of serious infections.I need a hip replacement due to severe arthritis.I am under 75 years old.I am using Medacta hip components not typically prescribed for my condition.My hip has a deformity due to an injury.I have inflammatory arthritis, such as rheumatoid arthritis.I have had surgery on my hip before.I have had a fracture around the time of surgery.I have been diagnosed with severe osteoporosis.
Research Study Groups:
This trial has the following groups:- Group 1: Femoral Component:Medacta Masterloc Stem and Medacta MPACT cup
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Who else is applying?
What site did they apply to?
Tucson Othropedic Institute
What portion of applicants met pre-screening criteria?
Met criteria
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