The Medacta Quadra-P Anteverted Study

NCT ID: NCT05460715

Last Updated: 2025-09-29

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 300 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-07-30
• Study Completion Date: 2032-07-31

Brief Summary

This is a Post-Marketing Surveillance of Quadra-P anteverted stem prosthesis.

Detailed Description

The primary objective of this study is to evaluate the 10-year survival of the anteverted Quadra-P stem in patients operated for primary total hip arthroplasty, according to the inclusion criteria.

Secondary objectives:

• To assess clinical performance by Harris Hip score collected during preoperative and postoperative visits at 3 months, 1, 2, 5, 7 and 10 years.
• Assess radiological performance by standard radiographic examination performed preoperatively, postoperatively before discharge and during postoperative visits at 3 months, 1, 2, 5, 7 and 10 years.
• Assessing the patient's perception of the prosthetic joint by means of FJS questionnaire collected during the preoperative visit and postoperative visits at 3 months and at 1, 2, 5, 7 and 10 years after surgery.
• Assessment of functional recovery by gait analysis study
• Collect the rate of complications throughout the course of the study

Conditions

Arthrosis; Traumatic Arthritis; Rheumatoid Polyarthritis; Congenital Hip Dysplasia; Avascular Necrosis of the Femoral Head

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Quadra P anteverted

• Assess clinical performance by Harris Hip score collected during preoperative and postoperative visits at 3 months, 1, 2, 5, 7 and 10 years.
• Assess radiological performance by standard radiographic examination performed before surgery, after surgery before discharge and during postoperative visits at 3 months, 1, 2, 5, 7 and 10 years.
• Assessing the patient's perception of the prosthetic joint by means of FJS questionnaire collected during the preoperative visit and postoperative visits at 3 months and at 1, 2, 5, 7 and 10 years after surgery.
• Assessment of functional recovery by gait analysis study
• Collect the rate of complications throughout the course of the study

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medacta International SA

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Istituto Ortopedico Franco Scalabrino

Messina, Messina, Italy

Countries

Italy

Other Identifiers

P01.001.20

Identifier Type: -

Identifier Source: org_study_id