Back to resultsAMIStem Primary Hip System Prospective Post-marketing Multi-centre Surveillance Study
Primary Purpose
Osteoarthritis, Arthritis, Avascular Necrosis
Status
Active
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
AMIStem Hip System
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis
Eligibility 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.
Sites / Locations
- Uniklinik Balgrist
- The Elective Orthopaedic Centre (EOC)
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
AMIStem Hip System
Arm Description
Patients who comply with the protocol and received an AMIStem femoral component.
Outcomes
Primary Outcome Measures
Assessment of implant survivorship using Kaplan Meier curve
Secondary Outcome Measures
Assessment of the patient's physical level of activity using the Oxford Hip Score
Assessment of the improvement in quality of life and joint movement using the EuroQol-5D score
Assessment of implant survivorship as a measure of safety using Kaplan Meier curve
Assessment of the clinical outcome following total hip replacement using the Harris Hip Score
Full Information
NCT ID
NCT01107340
First Posted
April 15, 2010
Last Updated
October 5, 2022
Sponsor
Medacta International SA
1. Study Identification
Unique Protocol Identification Number
NCT01107340
Brief Title
AMIStem Primary Hip System Prospective Post-marketing Multi-centre Surveillance Study
Official Title
AMIStem Primary Hip System Prospective Post-marketing Multi-centre Surveillance Study
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 2010 (undefined)
Primary Completion Date
February 2028 (Anticipated)
Study Completion Date
February 2028 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medacta International SA
4. Oversight
5. Study Description
Brief Summary
This is a multicentre post-marketing prospective study to evaluate performance and clinical outcomes of AMIIStem primary hip system.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Arthritis, Avascular Necrosis, Fracture of the Femoral Neck or Head, Congenital Hip Dysplasia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
500 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
AMIStem Hip System
Arm Type
Other
Arm Description
Patients who comply with the protocol and received an AMIStem femoral component.
Intervention Type
Device
Intervention Name(s)
AMIStem Hip System
Primary Outcome Measure Information:
Title
Assessment of implant survivorship using Kaplan Meier curve
Time Frame
10 years after surgery
Secondary Outcome Measure Information:
Title
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
Title
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
Title
Assessment of implant survivorship as a measure of safety using Kaplan Meier curve
Time Frame
6 months, 3 years, 5 years, 7.5 years, 10 years after surgery
Title
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
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard E Field, PhD FRCS
Organizational Affiliation
British Orthopaedic Association
Official's Role
Principal Investigator
Facility Information:
Facility Name
Uniklinik Balgrist
City
Zurich
ZIP/Postal Code
8008
Country
Switzerland
Facility Name
The Elective Orthopaedic Centre (EOC)
City
Epsom
State/Province
Surrey
ZIP/Postal Code
KT18 7EG
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
AMIStem Primary Hip System Prospective Post-marketing Multi-centre Surveillance Study
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