The Medacta Quadra-P Anteverted Study

Traumatic Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05460715
• Other study ID #: P01.001.20
• Status: Recruiting
• Start date: July 30, 2021
• Est. completion date: July 2032

Study information

• Verified date: March 2023
• Source: Medacta International SA
• Contact: Arianna Girardi
• Phone: +41 91 696 60 60
• Email: girardi[@]medacta.ch
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: July 2032
• Est. primary completion date: July 2032
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthrosis
• Avascular Necrosis of the Femoral Head
• Congenital Hip Dysplasia
• Developmental Dysplasia of the Hip
• Hip Dislocation
• Hip Dislocation, Congenital
• Necrosis
• Osteoarthritis
• Rheumatoid Polyarthritis
• Traumatic Arthritis

Intervention

Device:
• 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

Locations

Country	Name	City	State
Italy	Istituto Ortopedico Franco Scalabrino	Messina

Sponsors (1)

Lead Sponsor	Collaborator
Medacta International SA

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate the 10-year survival of the anteverted Quadra-P stem	% survival rate	10 years
Secondary	Assess clinical performance	Harris Hip score (HHS) (0 minimum-100 maximum)	at 3 months, 1, 2, 5, 7 and 10 years.
Secondary	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.
Secondary	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.
Secondary	Assessment of functional recovery	Assessment of functional recovery by gait analysis study	at pre-op, 3 months and at 1 year after surgery.
Secondary	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.