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

This study is currently recruiting participants.
Verified April 2016 by Medacta International SA
Sponsor:
ClinicalTrials.gov Identifier:
NCT01107340
First Posted: April 20, 2010
Last Update Posted: March 23, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Medacta International SA
April 15, 2010
April 20, 2010
March 23, 2017
February 2010
September 2017   (Final data collection date for primary outcome measure)
Assessment of the clinical outcome following total hip replacement using the Harris Hip Score [ Time Frame: 6 months after surgery ]
Assessment of patient improvement (subjective and objective) after surgery using the Harris Hip Score [ Time Frame: 6 months after surgery ]
Complete list of historical versions of study NCT01107340 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • Clinical assessment of patient using the Harris Hip Score [ Time Frame: pre-op, 6 months, 3 years, 5 years, 7.5 years, 10 years after surgery ]
Not Provided
Not Provided
 
AMIStem Primary Hip System Prospective Post-marketing Multi-centre Surveillance Study
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.
Not Provided
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Osteoarthritis
  • Arthritis
  • Avascular Necrosis
  • Fracture of the Femoral Neck or Head
  • Congenital Hip Dysplasia
Device: AMIStem Hip System
AMIStem Hip System
Patients who comply with the protocol and received an AMIStem femoral component.
Intervention: Device: AMIStem Hip System
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
500
September 2027
September 2017   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
Child, Adult, Senior
No
Contact: Mara Colombo 0041 91 6966060 ext 011 colombo@medacta.ch
Switzerland,   United Kingdom
 
 
NCT01107340
P01.004.11
Not Provided
Not Provided
Not Provided
Medacta International SA
Medacta International SA
Not Provided
Principal Investigator: Richard E Field, PhD FRCS(Orth) British Orthopaedic Association
Medacta International SA
April 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP