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

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.

Study Overview

• Status: Completed
• Conditions: Arthritis; Osteoarthritis; Avascular Necrosis; Congenital Hip Dysplasia; Fracture of the Femoral Neck or Head
• Intervention / Treatment: Procedure: Anterior Minimally Invasive Approach (AMIS)

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Bavaria
    • Dillingen an der Donau, Bavaria, Germany, 89407
      • St. Elisabeth Dillingen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Quadra Group	Procedure: Anterior Minimally Invasive Approach (AMIS)
Active Comparator: AMIStem Group	Procedure: Anterior Minimally Invasive Approach (AMIS)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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.	0-12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes From Baseline in Patients' Function. Clinical Evaluation Using the Harris Hip Score	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.	6 weeks, 6 months, 1 year
Changes From Baseline in Patient's Activity Level. Assessment Using the High Activity Arthroplasty Score.	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.	6 months, 1 year
Radiological Evaluation to Assess the Fixation and Stability of Femoral and Acetabular Components.	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.	6 months, 1 year

Collaborators and Investigators

• Sponsor: Medacta International SA
• Investigators: Principal Investigator: Martin Nolde, Dr. Med., DGOOC; BVO; BVASK

Study record dates

Study Major Dates

• Study Start: September 1, 2010
• Primary Completion (Actual): September 1, 2012
• Study Completion (Actual): September 1, 2012

Study Registration Dates

• First Submitted: January 26, 2011
• First Submitted That Met QC Criteria: January 27, 2011
• First Posted (Estimated): January 28, 2011

Study Record Updates

• Last Update Posted (Estimated): October 9, 2025
• Last Update Submitted That Met QC Criteria: September 22, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Pathologic Processes; Joint Diseases; Rheumatic Diseases; Necrosis; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathological Conditions, Signs and Symptoms; Developmental Dysplasia of the Hip; Arthritis; Osteoarthritis; Hip Dislocation, Congenital; Osteonecrosis
• Other Study ID Numbers: P01.004.14