AMIStem Primary Hip System Prospective Post-marketing Multi-centre Surveillance Study
This study is currently recruiting participants.
(see Contacts and Locations)
Verified April 2016 by Medacta International SA
Sponsor:
Medacta International SA
Information provided by (Responsible Party):
Medacta International SA
ClinicalTrials.gov Identifier:
NCT01107340
First received: April 15, 2010
Last updated: April 7, 2016
Last verified: April 2016
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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 |
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: | March 2026 |
| Estimated Primary Completion Date: | September 2016 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
AMIStem Hip System
Patients who comply with the protocol and received an AMIStem femoral component.
|
Device: AMIStem Hip System |
Eligibility| Ages Eligible for Study: | Child, Adult, Senior |
| 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01107340
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
| Responsible Party: | Medacta International SA |
| ClinicalTrials.gov Identifier: | NCT01107340 History of Changes |
| Other Study ID Numbers: | P01.004.11 |
| Study First Received: | April 15, 2010 |
| Last Updated: | April 7, 2016 |
| Health Authority: | United Kingdom: Research Ethics Committee Switzerland: Ethikkommission |
Additional relevant MeSH terms:
|
Osteoarthritis Necrosis Hip Dislocation Hip Dislocation, Congenital Arthritis Joint Diseases Musculoskeletal Diseases |
Rheumatic Diseases Pathologic Processes Dislocations Wounds and Injuries Hip Injuries Musculoskeletal Abnormalities Congenital Abnormalities |
ClinicalTrials.gov processed this record on September 26, 2016