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

• Sponsor: Medacta International SA (Industry)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT01107340
• Collaborator: (none)
• Enrollment: 500
• Locations: 2
• Arm: 1
• Duration (Months): 216
• Patients Per Site: 250
• Patients Per Site Per Month: 1.2

Study Details

Study Description

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	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 500 participants
• Allocation: N/A
• 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: Feb 1, 2010
• Anticipated Primary Completion Date: Feb 1, 2028
• Anticipated Study Completion Date: Feb 1, 2028

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Assessment of implant survivorship using Kaplan Meier curve [10 years after surgery]

Secondary Outcome Measures

1. Assessment of the patient's physical level of activity using the Oxford Hip Score [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 [pre-op, annually post-op up to 10 years]

3. Assessment of implant survivorship as a measure of safety using Kaplan Meier curve [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 [pre-op, 6 months, 3 years, 5 years, 7.5 years, 10 years after surgery]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Uniklinik Balgrist	Zurich		Switzerland	8008
2	The Elective Orthopaedic Centre (EOC)	Epsom	Surrey	United Kingdom	KT18 7EG

Sponsors and Collaborators

• Medacta International SA

Investigators

• Principal Investigator: Richard E Field, PhD FRCS, British Orthopaedic Association

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Medacta International SA
• ClinicalTrials.gov Identifier: NCT01107340
• Other Study ID Numbers: P01.004.11
• First Posted: Apr 20, 2010
• Last Update Posted: Feb 24, 2021
• Last Verified: Feb 1, 2021

• Additional relevant MeSH terms: Hip Dislocation; Developmental Dysplasia of the Hip; Hip Dislocation, Congenital; Necrosis

Study Results

No Results Posted as of Feb 24, 2021