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Active, Not Recruiting

NCT Number: NCT01107340

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

This is a multicentre post-marketing prospective study to evaluate performance and clinical outcomes of AMIIStem primary hip system.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Osteoarthritis Arthritis Avascular Necrosis Bone Diseases Congenital Abnormalities Congenital Hip Dysplasia Congenital, Hereditary, and Neonatal Diseases and Abnormalities Developmental Dysplasia of the Hip Fracture of the Femoral Neck or Head Hip Dislocation, Congenital Joint Diseases Musculoskeletal Abnormalities Musculoskeletal Diseases Necrosis Osteonecrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Rheumatic Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Uniklinik Balgrist, Zurich, Switzerland

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

AMIStem Hip System

Device

Primary outcomes

  1. Assessment of implant survivorship using Kaplan Meier curve

    Time frame: 10 years after surgery

Secondary outcomes

  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 using Kaplan Meier curve

    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

Sponsors and collaborators

Lead sponsor

Medacta International SA

Industry

Registry information

Important dates

Study start
2010
Primary completion
2028
Study completion
2028
First posted
Apr 20, 2010
Registry last updated
Dec 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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