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Active, Not Recruiting

NCT Number: NCT05460715

The Medacta Quadra-P Anteverted Study

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Quadra P anteverted

Device
  • 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

Primary outcomes

  1. Evaluate the 10-year survival of the anteverted Quadra-P stem

    Time frame: 10 years

    % survival rate

Secondary outcomes

  1. Assess clinical performance

    Time frame: at 3 months, 1, 2, 5, 7 and 10 years.

    Harris Hip score (HHS) (0 minimum-100 maximum)

  2. Assess radiological performance

    Time frame: 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

  3. Assessing the patient's perception of the prosthetic joint

    Time frame: at 3 months and at 1, 2, 5, 7 and 10 years after surgery.

    Forgotten Joint Score (FJS) (0 minimum-100 maximum)

  4. Assessment of functional recovery

    Time frame: at pre-op, 3 months and at 1 year after surgery.

    Assessment of functional recovery by gait analysis study

  5. Collect the rate of complications

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Medacta International SA

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2032
Study completion
2032
First posted
Jul 15, 2022
Registry last updated
Sep 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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