The Medacta Quadra-P Anteverted Study

Sponsor

Medacta International SA (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05460715

Collaborator

(none)

300

Enrollment

Location

131.1

Anticipated Duration (Months)

2.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Arthrosis Traumatic Arthritis Rheumatoid Polyarthritis Congenital Hip Dysplasia Avascular Necrosis of the Femoral Head	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 Design

Study Type:

Observational

Anticipated Enrollment :

300 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jul 30, 2021

Anticipated Primary Completion Date :

Jul 1, 2032

Anticipated Study Completion Date :

Jul 1, 2032

Outcome Measures

Primary Outcome Measures

Evaluate the 10-year survival of the anteverted Quadra-P stem [10 years]
% survival rate

Secondary Outcome Measures

Assess clinical performance [at 3 months, 1, 2, 5, 7 and 10 years.]
Harris Hip score (HHS) (0 minimum-100 maximum)
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
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)
Assessment of functional recovery [at pre-op, 3 months and at 1 year after surgery.]
Assessment of functional recovery by gait analysis study
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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