This trial is active, not recruiting.

Conditions osteoarthritis, arthritis, avascular necrosis, fracture of the femoral neck or head, congenital hip dysplasia
Treatment anterior minimally invasive approach (amis)
Sponsor Medacta International SA
Start date September 2010
End date September 2012
Trial size 40 participants
Trial identifier NCT01285843, P01.004.14


This is a monocentric, prospective, randomized clinical survey to verify if the periprosthetic remodelling brought about either the AMIStem or the Quadra femoral component is equivalent.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Masking open label
Primary purpose treatment
(Active Comparator)
anterior minimally invasive approach (amis)
(Active Comparator)
anterior minimally invasive approach (amis)

Primary Outcomes

Compare periprosthetic bone mineral density (BMD) in patients that have undergone a total hip arthroplasty (THA) via the direct anterior approach receiving either a Quadra or AMIStem femoral component.
time frame: 0-12 months

Secondary Outcomes

Changes from baseline in patients' function. Clinical evaluation using the Harris Hip Score
time frame: 6 weeks, 6 months, 1 year
Changes from baseline in patient's activity level. Assessment using the High Activity Arthroplasty Score.
time frame: 6 months, 1 year
Radiological evaluation to assess the fixation and stability of femoral and acetabular components.
time frame: 6 months, 1 year

Eligibility Criteria

Male or female participants of any age.

Inclusion Criteria: - Patients who are willing and able to provide written informed consent for participation in the study. Written informed consent must be obtained prior to the patient's surgery. - Patients presenting with disease that meets the indications for use for Medacta implants defined by this study (on-label use (enclosure 2)). - Patients must be willing to comply with the pre and post-operative evaluation schedule. - Patients with only one lower limb arthroplasty Exclusion Criteria: - Patient with metabolic bone diseases, use of steroids or other drugs affecting bone metabolism - Patients with osteoporosis (pre-op T-score < -2,5) - Patients with significant comorbidities - Patients with both hip and knee arthroplasty - Patients with restricted mobility - Patient with severe hip contracture - Those with one or more medical conditions identified as a contraindication defined by the labeling on any Medacta implants used in this study

Additional Information

Official title Periprosthetic Bone Mineral Density After Total Hip Arthroplasty Performed Through a Minimally Invasive Anterior Approach (AMIS) With Either an AMIStem or a Quadra Femoral Component.
Principal investigator Martin Nolde, Dr. Med.
Trial information was received from ClinicalTrials.gov and was last updated in July 2011.
Information provided to ClinicalTrials.gov by Medacta International SA.