The Medacta Quadra-P Anteverted Study

Launched by MEDACTA INTERNATIONAL SA · Jul 14, 2022

Keywords

ClinConnect Summary

The Medacta Quadra-P Anteverted Study is a clinical trial that is looking at a specific hip implant called the Quadra-P anteverted stem prosthesis. This study is designed for adults who suffer from various hip conditions, including arthritis, hip dysplasia, and avascular necrosis (a condition where the blood supply to the bone is reduced, leading to bone death). The trial is currently recruiting participants who are between 18 and 75 years old and who are planning to have a total hip replacement surgery using this particular implant.

To participate, individuals must be eligible for hip replacement surgery and willing to provide written consent. However, people with certain medical conditions, like infections or serious bone issues, may not be included in the study. Participants can expect to have their surgery as planned and will be part of a follow-up process to monitor their recovery and the performance of the implant. This study aims to gather more information about how well the Quadra-P prosthesis works in real-life situations after it has been approved for use.

Gender

ALL

Eligibility criteria

• 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