AMIStem Primary Hip System Prospective Post-marketing Multi-centre Surveillance Study

This is a multicentre post-marketing prospective study to evaluate performance and clinical outcomes of AMIIStem primary hip system.

Study Overview

• Status: Active, not recruiting
• Conditions: Arthritis; Osteoarthritis; Avascular Necrosis; Congenital Hip Dysplasia; Fracture of the Femoral Neck or Head
• Intervention / Treatment: Device: AMIStem Hip System

• Study Type: Interventional
• Enrollment (Estimated): 500
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Zurich, Switzerland, 8008
    • Uniklinik Balgrist
• United Kingdom
  • Surrey
    • Epsom, Surrey, United Kingdom, KT18 7EG
      • The Elective Orthopaedic Centre (EOC)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patient is a good candidate for a primary hip arthroplasty using AMIStem Hip System
• Patient is willing and able to give informed consent to participate in the follow-up program
• Patient is suitable for surgery and able to participate in the follow-up program.
• Those presenting with disease that meets the indication for use for Medacta implants defined in the study (on-label use)

Exclusion Criteria:

• Acute systemic or chronic infection
• Skeletal immaturity
• Severe muscular, neurological, vascular deficiency or other pathologies of the affected limb that may compromise the stability of the implant.
• Bone condition that may compromise the stability of the implant.
• Patient who are unwilling or unable to give consent, or to comply with the protocol and the follow-up program.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: AMIStem Hip System; Patients who comply with the protocol and received an AMIStem femoral component.	Device: AMIStem Hip System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Assessment of implant survivorship using Kaplan Meier curve	10 years after surgery

Secondary Outcome Measures

Outcome Measure	Time Frame
Assessment of the patient's physical level of activity using the Oxford Hip Score	pre-op, annually post-op up to 10 years
Assessment of the improvement in quality of life and joint movement using the EuroQol-5D score	pre-op, annually post-op up to 10 years
Assessment of implant survivorship as a measure of safety using Kaplan Meier curve	6 months, 3 years, 5 years, 7.5 years, 10 years after surgery
Assessment of the clinical outcome following total hip replacement using the Harris Hip Score	pre-op, 6 months, 3 years, 5 years, 7.5 years, 10 years after surgery

Collaborators and Investigators

• Sponsor: Medacta International SA
• Investigators: Principal Investigator: Richard E Field, PhD FRCS, British Orthopaedic Association

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2010
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2028

Study Registration Dates

• First Submitted: April 15, 2010
• First Submitted That Met QC Criteria: April 19, 2010
• First Posted (Estimated): April 20, 2010

Study Record Updates

• Last Update Posted (Actual): December 4, 2023
• Last Update Submitted That Met QC Criteria: December 1, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Wounds and Injuries; Congenital Abnormalities; Joint Diseases; Musculoskeletal Diseases; Hip Injuries; Musculoskeletal Abnormalities; Joint Dislocations; Necrosis; Hip Dislocation; Developmental Dysplasia of the Hip; Hip Dislocation, Congenital
• Other Study ID Numbers: P01.004.11