The Medacta Quadra-P Anteverted Study

Recruiting

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

• Registration Number: NCT05460715
• Lead Sponsor: Medacta International SA

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

Study Timeline

• Study Start: 2021-07-30
• Study First Submitted: 2022-07-12
• Study First Submitted QC: 2022-07-14
• Study First Posted: 2022-07-15
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-10
• Last Update Posted: 2023-03-13
• Primary Completion: 2032-07
• Study Completion: 2032-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluate the 10-year survival of the anteverted Quadra-P stem	10 years	% survival rate

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Istituto Ortopedico Franco Scalabrino; 🇮🇹 Messina, Italy