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Procedure
Small Incision Hip Replacement for Total Hip Replacement
N/A
Waitlist Available
Research Sponsored by Rothman Institute Orthopaedics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patient has primary diagnosis of non-inflammatory degenerative joint disease.
Patient is a male or non-pregnant female age 18 years or older at the time of study device implantation.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial will compare two types of femoral stems used in hip replacement surgery to see which one has better short-term outcomes.
Who is the study for?
This trial is for adults over 18 needing a first-time hip replacement due to non-inflammatory joint disease. They must be able to follow the study's procedures and have signed consent forms. It's not for those with infections, immune suppression, previous hip replacements needing revision, BMI over 40, or allergies to implant materials.Check my eligibility
What is being tested?
The study compares short-term outcomes of two different femoral stems used in total hip arthroplasty: Fitmore Femoral stem versus M/L Taper Femoral stem. The goal is to see which one works better following surgery.See study design
What are the potential side effects?
While specific side effects are not listed here, typical risks associated with total hip arthroplasty may include pain at the site, infection risk post-surgery, possible reaction to anesthesia, and complications related to the implants.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with a non-inflammatory joint condition.
Select...
I am 18 or older and not pregnant.
Select...
I am eligible for a hip replacement without using bone cement.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ within six weeks post-operative
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within six weeks post-operative
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Short term hip function
Secondary outcome measures
Short-Term Pain Levels of direct anterior and anterolateral surgical approaches
Trial Design
2Treatment groups
Active Control
Group I: Total Hip Arthroplasty using Fitmore femoral stemActive Control1 Intervention
Group II: Total Hip Arthroplasty using M/L Taper Femoral stemActive Control1 Intervention
Find a Location
Who is running the clinical trial?
Rothman Institute OrthopaedicsLead Sponsor
121 Previous Clinical Trials
21,578 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am willing and able to follow through with all after-surgery check-ups and rehab.You are allergic to the materials used in the medical device.I need surgery to fix my previous hip replacement.I do not have an active or suspected infection.I have been diagnosed with a non-inflammatory joint condition.I am 18 or older and not pregnant.I am eligible for a hip replacement without using bone cement.
Research Study Groups:
This trial has the following groups:- Group 1: Total Hip Arthroplasty using Fitmore femoral stem
- Group 2: Total Hip Arthroplasty using M/L Taper Femoral stem
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.
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