Evaluating the Quadra-P Anteverted Stem Prosthesis for Hip Surgery

Prospective Multicentre Study to Evaluate the Long-term Performance of Anteverted Femoral Stems in Total Hip Arthroplasty

This study is testing how well the Quadra-P hip prosthesis works and lasts for patients getting hip replacement surgery over a 10-year period.

Quick facts

• Study type: Observational
• Enrollment: 300 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Medacta International SA (industry)
• Locations: 1 site (Messina)
• Trial ID: NCT05460715 on ClinicalTrials.gov

What this trial studies

This observational study focuses on the long-term survival and performance of the Quadra-P anteverted stem prosthesis in patients undergoing primary total hip arthroplasty. It aims to assess clinical outcomes using the Harris Hip score, radiological performance through standard imaging, and patient perceptions via the FJS questionnaire over a 10-year period. Additionally, functional recovery will be evaluated through gait analysis, and the study will monitor complication rates throughout the follow-up period.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 to 75 with conditions such as primary hip arthrosis, post-traumatic arthrosis, dysplasia, or avascular necrosis of the femoral head who are eligible for total hip arthroplasty.

Not a fit: Patients with acute or chronic infections, femoral neck fractures, or mental conditions that impair consent or follow-up will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable insights into the long-term effectiveness and safety of the Quadra-P prosthesis, potentially improving outcomes for patients undergoing hip replacement surgery.

How similar studies have performed: Other studies evaluating similar prosthetic approaches have shown promising results, indicating that this methodology is supported by prior research.

Eligibility criteria

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

Where this trial is running

Messina

• Istituto Ortopedico Franco Scalabrino — Messina, Italy (RECRUITING)

Study contacts

• Study coordinator: Arianna Girardi

Conditions: Arthrosis, Traumatic Arthritis, Rheumatoid Polyarthritis, Congenital Hip Dysplasia, Avascular Necrosis of the Femoral Head, total hip arthroplasty, Quadra P anteverted, Medacta