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
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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 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 |

Arm | Intervention/treatment |
---|---|
AMIStem Hip System
Patients who comply with the protocol and received an AMIStem femoral component.
|
Device: AMIStem Hip System |
- Assessment of the clinical outcome following total hip replacement using the Harris Hip Score [ Time Frame: 6 months 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 ]
- 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 ]

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, Learn About Clinical Studies.
Ages Eligible for Study: | Child, Adult, Senior |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

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
Contact: Mara Colombo | 0041 91 6966060 ext 011 | colombo@medacta.ch |
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) |
Principal Investigator: | Richard E Field, PhD FRCS(Orth) | British Orthopaedic Association |
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 |