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

This study is currently recruiting participants.
Verified March 2013 by Medacta International SA
Sponsor:
Information provided by:
Medacta International SA
ClinicalTrials.gov Identifier:
NCT01107340
First received: April 15, 2010
Last updated: March 15, 2013
Last verified: March 2013
History of Changes
  Purpose

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


Condition Intervention
Osteoarthritis
Arthritis
Avascular Necrosis
Fracture of the Femoral Neck or Head
Congenital Hip Dysplasia
 Device: AMIStem Hip System

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: AMIStem Primary Hip System Prospective Post-marketing Multi-centre Surveillance Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Medacta International SA:

Primary Outcome Measures:
  • Assessment of the clinical outcome following total hip replacement using the Harris Hip Score [ Time Frame: 6 months after surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Assessment of the patient's physical level of activity using the Oxford Hip Score [ Time Frame: pre-op, annually post-op up to 10 years ] [ Designated as safety issue: No ]
  • Assessment of the improvement in quality of life and joint movement using the EuroQol-5D score [ Time Frame: pre-op, annually post-op up to 10 years ] [ Designated as safety issue: No ]
  • Assessment of implant survivorship as a measure of safety and tolerability [ Time Frame: 6 months, 3 years, 5 years, 7.5 years, 10 years after surgery ] [ Designated as safety issue: Yes ]
  • Assessment of the clinical outcome following total hip replacement using the Harris Hip Score [ Time Frame: pre-op, 6 months, 3 years, 5 years, 7.5 years, 10 years after surgery ] [ Designated as safety issue: No ]

Estimated Enrollment: 500
Study Start Date: February 2010
Estimated Study Completion Date: February 2024
Estimated Primary Completion Date: February 2024 (Final data collection date for primary outcome measure)
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01107340

Contacts
Contact: Mara Colombo 0041 91 6966060 ext 011 colombo@medacta.ch

Locations
Switzerland
Uniklinik Balgrist Recruiting
Zurich, Switzerland, 8008
Principal Investigator: Claudio Dora, PD Dr            
United Kingdom
The Elective Orthopaedic Centre (EOC) Recruiting
Epsom, Surrey, United Kingdom, KT18 7EG
Principal Investigator: Richard E Field, PhD FRCS(Orth)            
Sponsors and Collaborators
Medacta International SA
Investigators
Principal Investigator: Richard E Field, PhD FRCS(Orth) British Orthopaedic Association
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT01107340     History of Changes
Other Study ID Numbers: P01.004.11
Study First Received: April 15, 2010
Last Updated: March 15, 2013
Health Authority: United Kingdom: Research Ethics Committee
Switzerland: Ethikkommission

Additional relevant MeSH terms:
Arthritis
Hip Dislocation, Congenital
Necrosis
Osteonecrosis
Osteoarthritis
Joint Diseases
 Musculoskeletal Diseases
Musculoskeletal Abnormalities
Congenital Abnormalities
Pathologic Processes
Bone Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on June 17, 2013