The Medacta Quadra-P Anteverted Study (NCT05460715) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
The Medacta Quadra-P Anteverted Study
Italy300 participantsStarted 2021-07-30
Plain-language summary
This is a Post-Marketing Surveillance of Quadra-P anteverted stem prosthesis.
Who can participate
Age range18 Years – 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Subjects suffering from primary hip arthrosis, post-traumatic arthrosis, dysplasia or avascular necrosis of the femoral head, rheumatoid arthritis
* Adult subjects between 18 and 75 years of age on the date of surgery
* Subjects eligible for primary total hip arthroplasty surgery for whom the anterior Quadra-P femoral component will be implanted according to the indications for use of the implant
* Subjects who are willing and able to provide written informed consent for participation in the study. Written informed consent must be obtained prior to surgery.
For the anatomical-functional subgroup:
\- Adult subjects aged between 18 and 65 years at the date of surgery who have agreed to undergo the gait analysis study.
Exclusion Criteria:
* Subjects with acute or chronic infection
* Subjects with a femoral neck fracture
* Subjects with mental conditions that impair their ability to consent to the study, to complete required questionnaires or to complete follow-up visits
* Subjects with severe deformities, at the discretion of the surgeon
* Subjects with metabolic disorders that may involve bone metabolism for which an uncemented implant would be contraindicated
* Subjects with muscular atrophy or neuromuscular diseases
* Subjects allergic to the materials used during surgery
* Subjects unable or unwilling to provide consent for participation in the study
* Any other condition not mentioned in the inclusion criteria
What they're measuring
1
Evaluate the 10-year survival of the anteverted Quadra-P stem