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

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ClinicalTrials.gov Identifier: NCT01107340
Recruitment Status : Recruiting
First Posted : April 20, 2010
Last Update Posted : March 23, 2017
Sponsor:
Information provided by (Responsible Party):
Medacta International SA

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
This is a multicentre post-marketing prospective study to evaluate performance and clinical outcomes of AMIIStem primary hip system.

Condition or disease Intervention/treatment Phase
Osteoarthritis Arthritis Avascular Necrosis Fracture of the Femoral Neck or Head Congenital Hip Dysplasia Device: AMIStem Hip System Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: AMIStem Primary Hip System Prospective Post-marketing Multi-centre Surveillance Study
Study Start Date : February 2010
Estimated Primary Completion Date : September 2017
Estimated Study Completion Date : September 2027

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U.S. FDA Resources

Arms and Interventions
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
AMIStem Hip System
Patients who comply with the protocol and received an AMIStem femoral component.
 Device: AMIStem Hip System


Outcome Measures
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Primary Outcome Measures :
  1. Assessment of the clinical outcome following total hip replacement using the Harris Hip Score [ Time Frame: 6 months after surgery ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Medacta International SA
ClinicalTrials.gov Identifier: NCT01107340     History of Changes
Other Study ID Numbers: P01.004.11
First Posted: April 20, 2010    Key Record Dates
Last Update Posted: March 23, 2017
Last Verified: April 2016

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