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

Not Applicable

Completed

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

• Registration Number: NCT01285843
• Lead Sponsor: Medacta International SA

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-09
• Study First Submitted: 2011-01-26
• Study First Submitted QC: 2011-01-27
• Study First Posted: 2011-01-28
• Status Verified: 2011-07
• Primary Completion: 2012-09
• Study Completion: 2012-09
• Results First Submitted: 2014-08-27
• Results First Submitted QC: 2014-09-09
• Results First Posted: 2014-09-15
• Last Update Submitted: 2016-08-26
• Last Update Posted: 2016-10-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Quadra Group	Anterior Minimally Invasive Approach (AMIS)	-
AMIStem Group	Anterior Minimally Invasive Approach (AMIS)	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Changes From Baseline in Patient's Activity Level. Assessment Using the High Activity Arthroplasty Score.	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.
Radiological Evaluation to Assess the Fixation and Stability of Femoral and Acetabular Components.	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.
Changes From Baseline in Patients' Function. Clinical Evaluation Using the Harris Hip Score	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.

Trial Locations

Locations (1)

St. Elisabeth Dillingen; 🇩🇪 Dillingen an der Donau, Bayern, Germany