BridgeMD
New treatment option for Hip Osteoarthritis
Official title Emphasys Radiostereometric Analysis
ClinicalTrials.gov ID: NCT06173713
What this study is testing
- What it's testing
- This study is designed as a prospective, multi-centre, non-randomized, non-controlled study. This study does not limit the procedures involved in the treatment of the subject as long as the protocol specified products are utilized.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 21 and older. Healthy volunteers may be eligible.
You may be able to join if
- Individuals requiring primary THA for a severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or...
- Individuals who are able to speak, read and comprehend the informed patient consent document and willing and able to provide informed patient consent...
- Individuals who are willing and able to return for follow-up as specified by the study protocol.
- Individuals who are a minimum age of 21 years at the time of consent.
- Individuals who are willing and able to complete the Subject Hip Outcomes questionnaires as specified by the study protocol.
You likely can't join if
- Individuals who have active local or systemic infection.
- Individuals who have loss of musculature, neuromuscular compromise or vascular compromise that would impact rehabilitation following surgery.
- Individuals with poor bone quality, such as osteoporosis, where in the surgeon's opinion, there could be considerable migration of the prosthesis or...
- Individuals with Charcot's or Paget's disease.
- Individuals who, in the judgement of the investigator, would not be a candidate for protocol allowable components to be used for their THA.
- Women who are pregnant or lactating.
See the full eligibility criteria
- Individuals requiring primary THA for a severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia, AVN of the femoral head or acute traumatic...
- Individuals who are able to speak, read and comprehend the informed patient consent document and willing and able to provide informed patient consent for participation in the study and have authorized the transfer of...
- Individuals who are willing and able to return for follow-up as specified by the study protocol.
- Individuals who are a minimum age of 21 years at the time of consent.
- Individuals who are willing and able to complete the Subject Hip Outcomes questionnaires as specified by the study protocol.
- Individuals who have active local or systemic infection.
- Individuals who have loss of musculature, neuromuscular compromise or vascular compromise that would impact rehabilitation following surgery.
- Individuals with poor bone quality, such as osteoporosis, where in the surgeon's opinion, there could be considerable migration of the prosthesis or require additional acetabular cup fixation using screws, or a...
- Individuals with Charcot's or Paget's disease.
- Individuals who, in the judgement of the investigator, would not be a candidate for protocol allowable components to be used for their THA.
- Women who are pregnant or lactating.
- Individuals who have had a contralateral hip that was implanted less than 6 months prior to the time of consent into this study or individuals that expect to have a contralateral hip implanted in the following 6 months...
- Individuals that have amputations in either leg that would impact rehabilitation following surgery.
- Individuals who are bedridden
- Individuals that have participated in a clinical investigation with an investigational product (drug or device) in the last three months.
- Individuals currently involved in any personal injury litigation, medical-legal or worker's compensation claims.
- Individuals, in the opinion of the Investigator, who are drug or alcohol abusers or have a psychological disorder that could affect their ability to complete patient reported questionnaires or be compliant with...
- Individuals diagnosed and taking prescription medications to treat a muscular disorder that limits mobility due to sever stiffness and pain such as fibromyalgia or polymyalgia.
- Subject has a medical condition with less than 2 years life expectancy.
- Individual has a BMI \>45 kg/m2.
The study team makes the final eligibility decision.
Where it's taking place
- Winnipeg, Manitoba, Canada
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 21 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Winnipeg, Manitoba, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.