The Medacta Quadra-P Anteverted Study

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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Arthrosis; Congenital Hip Dysplasia; Traumatic Arthritis; Rheumatoid Polyarthritis; Avascular Necrosis of the Femoral Head
• Intervention / Treatment: Device: Quadra P anteverted

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

• Study Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

Study Locations

• Italy
  • Messina
    • Messina, Messina, Italy
      • Istituto Ortopedico Franco Scalabrino

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

The aim of the study is to monitor the clinical performance and survival of the Quadra-P antevert stem when used according to its indications. Since patients are not subjected to additional risks or procedures compared to standard practice, the total number of patients was defined on the basis of the surgeon's potential and observational studies of the same type already published in the literature.

For the anatomical-functional subgroup, a sample size was defined to verify 10% speed increases between pre- and postoperative. Considering α = 5% and Power = 90%, 30 patients will be required.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate the 10-year survival of the anteverted Quadra-P stem	% survival rate	10 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assess clinical performance	Harris Hip score (HHS) (0 minimum-100 maximum)	at 3 months, 1, 2, 5, 7 and 10 years.
Assess radiological performance	Assess radiological performance by standard radiographic examination performed before surgery, after surgery before discharge and during postoperative visits	at pre-op, 3 months, 1, 2, 5, 7 and 10 years.
Assessing the patient's perception of the prosthetic joint	Forgotten Joint Score (FJS) (0 minimum-100 maximum)	at 3 months and at 1, 2, 5, 7 and 10 years after surgery.
Assessment of functional recovery	Assessment of functional recovery by gait analysis study	at pre-op, 3 months and at 1 year after surgery.
Collect the rate of complications	Collect the rate of complications throughout the course of the study	at pre-op, immediate post-op, 3 months, 1, 2, 5, 7 and 10 years.

Collaborators and Investigators

• Sponsor: Medacta International SA

Study record dates

Study Major Dates

• Study Start (Actual): July 30, 2021
• Primary Completion (Estimated): July 1, 2032
• Study Completion (Estimated): July 1, 2032

Study Registration Dates

• First Submitted: July 12, 2022
• First Submitted That Met QC Criteria: July 14, 2022
• First Posted (Actual): July 15, 2022

Study Record Updates

• Last Update Posted (Estimated): September 29, 2025
• Last Update Submitted That Met QC Criteria: September 23, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: total hip arthroplasty; Quadra P anteverted; Medacta
• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Pathologic Processes; Arthritis; Joint Diseases; Rheumatic Diseases; Necrosis; Musculoskeletal Abnormalities; Congenital Abnormalities; Osteonecrosis; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathological Conditions, Signs and Symptoms; Developmental Dysplasia of the Hip; Osteoarthritis; Hip Dislocation, Congenital; Femur Head Necrosis
• Other Study ID Numbers: P01.001.20

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• product manufactured in and exported from the U.S.: No