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NCT Number: NCT01285843

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

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.

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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

St. Elisabeth Dillingen

Dillingen an der Donau, Bavaria, 89407, Germany

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Anterior Minimally Invasive Approach (AMIS)

Procedure

Primary outcomes

  1. Compare Periprosthetic Bone Mineral Density (BMD), at 1y Postoperative, 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

  1. Changes From Baseline in Patients' Function. Clinical Evaluation Using the Harris Hip Score

    Time frame: 6 weeks, 6 months, 1 year

    The items in the Harris hip score (HHS) include an analysis of the operated hip according to pain, function, mobility and stability, and an analysis of deformities, in a scale form 0 point (the worst condition) to 100 points (the best condition). The Harris Hip Score will be used to assess the subjective and objective improvement in the patient. The usefulness of the score has been designed to estimate clinical outcomes after THA and demonstrated high reliability and validity.

    The HHS values at each time points, 6 weeks, 6 months and 1 year, and for each patient, will be reported as difference respect the preoperative value collected at preoperative.

  2. Changes From Baseline in Patient's Activity Level. Assessment Using the High Activity Arthroplasty Score.

    Time frame: 6 months, 1 year

    The HAAS was designed to detect subtle variations in functional ability after lower limb arthroplasty, in a scale from 0 (minimum, the worst condition) to 18 points (maximum, the best condition) The HAAS values at each time points, 6 months and 1 year, and for each patient, will be reported as difference respect the preoperative value collected at preoperative.

  3. Radiological Evaluation to Assess the Fixation and Stability of Femoral and Acetabular Components.

    Time frame: 6 months, 1 year

    Stability and fixation of both, femoral and acetabular component will be assessed counted number of events of stem subsidence, femoral and cup loosening, cup migration and presence of radiolucencies occurred during the study at 6 months and 1 year time points.

Sponsors and collaborators

Lead sponsor

Medacta International SA

Industry

Registry information

Official study 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.

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Jan 28, 2011
Registry last updated
Oct 9, 2025

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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