Hip Implants for Arthritis
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial evaluates the safety and effectiveness of a specific hip replacement (Total Hip Arthroplasty Implant) for patients in the EU after its approval for use. It targets individuals who have undergone total hip replacement surgery using specific components from MicroPort Orthopedics. Suitable candidates include those who had hip replacement surgery due to conditions like osteoarthritis or rheumatoid arthritis and received the implant with the specified components. The trial requires participants to attend follow-up visits and not participate in other conflicting studies. As a Phase 4 trial, it aims to understand how the already FDA-approved treatment benefits more patients, allowing participants to contribute to broader medical knowledge.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What is the safety track record for the Total Hip Arthroplasty Implant?
Research has shown that hip replacement implants, such as the PROFEMUR® TL modular femoral stem, generally perform well for patients. Tests indicate that these implants function as expected under normal conditions, suggesting they are safe and well-tolerated by most individuals.
Studies on similar hip implants support their long-term effectiveness, indicating that the implant parts tend to last a long time.
While the specific device in this trial is still under study for safety and effectiveness, its design is similar to approved devices. This similarity provides additional confidence in its safety for those considering joining the trial.12345Why are researchers enthusiastic about this study treatment?
The PROFEMUR® TL Modular Femoral Stem used in total hip arthroplasty is unique because it offers a modular design that allows surgeons to customize the implant to better fit each patient's anatomy. This flexibility can potentially improve joint stability and longevity, which is a significant advancement over traditional, one-size-fits-all hip implants. Additionally, the use of high-quality materials like ceramic and advanced polyethylene liners aims to reduce wear and tear, which could lead to fewer complications and longer-lasting results. Researchers are excited about these features as they may enhance patient outcomes and quality of life post-surgery.
What evidence suggests that this total hip arthroplasty implant is effective for hip replacement?
Research has shown that hip replacement surgery using adjustable parts can be very effective. In this trial, participants will receive a Total Hip Arthroplasty Implant, which includes components such as the PROFEMUR® TL modular femoral stem and MicroPort Orthopedics acetabular shell. Studies have found that these parts allow surgeons to make precise adjustments, improving the fit and function of the new joint. Tests indicate that the device performs well in everyday situations, suggesting it can handle daily activities effectively. Additionally, these implants have been linked to good long-term results, lasting up to 10 years. This evidence suggests that this type of hip replacement could be a reliable option for those needing the surgery.12678
Who Is on the Research Team?
Paul Beaule, MD
Principal Investigator
Ottawa Hospital Research Institute
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Post-operative Follow-up
Participants are monitored for component survivorship and functional outcomes
Long-term Follow-up
Participants continue to be monitored for long-term safety and effectiveness
What Are the Treatments Tested in This Trial?
Interventions
- Total Hip Arthroplasty Implant
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Single group previously implanted with the following combination of components: PROFEMUR® TL modular femoral stem, MicroPort Orthopedics acetabular shell, MicroPort Orthopedics polyethylene or ceramic liner, MicroPort Orthopedics metal or ceramic femoral head.
Find a Clinic Near You
Who Is Running the Clinical Trial?
MicroPort Orthopedics Inc.
Lead Sponsor
Citations
NCT02239783 | Post Market Clinical Follow-Up Study ...
The objectives of this study are to evaluate component survivorship and total functional outcome scores of implanted subjects at out to 10 years follow-up.
Modular Stems: Advantages and Current Role in Primary Total ...
Using modular femoral stems in total hip arthroplasty enables surgeons to make fine adjustments to individual joints and offers intraoperative flexibility.
MicroPort Orthopedics, Incorporated Mr. Matt Paul Regulatory ...
Successful results of testing support the expectation that the device will perform as intended under normal physiological loading conditions, ...
4.
ctv.veeva.com
ctv.veeva.com/study/post-market-clinical-follow-up-study-protocol-for-profemur-r-tl-modular-femoral-stemsPost Market Clinical Follow-Up Study Protocol for PROFEMUR ...
Sponsor is conducting this post market clinical follow-up (PMCF) study to evaluate the safety and efficacy of its total hip arthroplasty ...
MINIMA Short Stem Versus Standard Profemur (TL) ...
In our comparative study, we aimed to investigate the potential short-term efficacy of the MINIMA short stem comparing with the conventional TL ...
Long-Term Outcome of Metal-on-Metal Total Hip ...
This study aimed to report the long-term outcomes of total hip arthroplasty (THA) using a Conserve Plus (Wright Medical, Japan) metal-on-metal (MoM) acetabular ...
Profemur® TL Hip Stem
Designed for primary hip replacement surgery, the Profemur® TL Hip Stem is a dual tapered wedge stem with a unique geometry.
Outcomes of Total Hip Arthroplasty After Acetabular Open ...
All acetabular fractures in patients older than 60 years who presented between. 2007 and 2018 were reviewed. After the injury and assessment at.
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