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

NCT01107340 | Active Not Recruiting

• 1 other identifier: P01.004.11
• Study Type: interventional
• Target: 500
• Locations: 2 countries
• Sites: 2

Brief Summary

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

Conditions

Osteoarthritis; Arthritis; Avascular Necrosis; Fracture of the Femoral Neck or Head; Congenital Hip Dysplasia

Outcome Measures

Primary Outcomes (1)

• Assessment of implant survivorship using Kaplan Meier curve

  10 years after surgery

Secondary Outcomes (4)

• 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

Study Arms (1)

AMIStem Hip System

OTHER

Patients who comply with the protocol and received an AMIStem femoral component.

Device: AMIStem Hip System

Interventions

AMIStem Hip System DEVICE

AMIStem Hip System

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medacta International SA: lead

Study Sites (2)

Uniklinik Balgrist

Zurich, 8008, Switzerland

Location

The Elective Orthopaedic Centre (EOC)

Epsom, Surrey, KT18 7EG, United Kingdom

Location

MeSH Terms

Conditions

Osteoarthritis; Arthritis; Osteonecrosis; Hip Dislocation, Congenital

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Bone Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Developmental Dysplasia of the Hip; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Richard E Field, PhD FRCS

  British Orthopaedic Association

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2010
• First Posted: April 20, 2010
• Study Start: January 1, 2010
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2028
• Last Updated: December 16, 2024

Record last verified: 2024-12

Locations

CH (1); GB (1)