BridgeMD
New treatment option for Hip Dysplasia
Official title Shelf Acetabuloplasty With 3D Printed Implants as a New Treatment for Symptomatic Adult Hip Dysplasia
ClinicalTrials.gov ID: NCT07072832
What this study is testing
- What it's testing
- Hip dysplasia is a common orthopedic condition, defined as an abnormality in the shape, size and orientation of the femoral head, acetabulum or both. The most frequent presentation of hip dysplasia is the maldevelopment of the acetabulum, resulting in insufficient superior coverage of the femoral head, defined as a lateral center-edge angle (Wiberg) of less than 20 degrees.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 45
You may be able to join if
- Hip dysplasia based on AP x-ray with a LCEA of \<25°
- Groin pain and/or gait abnormalities, with no other explanatory hip pathology
- Aged at least 18 years and maximal 45 years at time of surgery (indicated age for PAO(19))
- Willing to comply with the study visit schedule during 12 month follow-up
- Able and willing to provide informed consent
You likely can't join if
- Previous acetabular surgery \>10yr of age
- Signs of osteoarthritis on x-ray (Tonnis classification \>1),
- Body mass index of more than 35
- Large labral tears visible on non-contrast MRI
- Pre-consultation known titanium allergy
- Pre-consultation known medical histories of diseases that per the investigator possibly affect the outcome: neuromuscular disease affecting the...
See the full eligibility criteria
- Hip dysplasia based on AP x-ray with a LCEA of \<25°
- Groin pain and/or gait abnormalities, with no other explanatory hip pathology
- Aged at least 18 years and maximal 45 years at time of surgery (indicated age for PAO(19))
- Willing to comply with the study visit schedule during 12 month follow-up
- Able and willing to provide informed consent
- Previous acetabular surgery \>10yr of age
- Signs of osteoarthritis on x-ray (Tonnis classification \>1),
- Body mass index of more than 35
- Large labral tears visible on non-contrast MRI
- Pre-consultation known titanium allergy
- Pre-consultation known medical histories of diseases that per the investigator possibly affect the outcome: neuromuscular disease affecting the stability of the hip, diseases affecting bone ingrowth and fixation...
- Pre-consultation known pregnant women or women who are planning to become pregnant during the duration of the study.
- Part of vulnerable population (e.g. Mentally disabled with cognitive impairment or mental disease)
- Currently participating in another investigational clinical trial.
- Unable to provide informed consent (e.g. insufficient language skills)
The study team makes the final eligibility decision.
Where it's taking place
- Geldrop, Netherlands
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
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, 18 years to 45 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Geldrop, Netherlands. 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.