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

Osteoarthritis Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01285843
• Other study ID #: P01.004.14
• Status: Completed
• Phase: N/A
• First received: January 26, 2011
• Last updated: September 9, 2014
• Start date: September 2010
• Est. completion date: September 2012

Study information

• Verified date: July 2011
• Source: Medacta International SA
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Avascular Necrosis
• Congenital Hip Dysplasia
• Fracture of the Femoral Neck or Head
• Hip Dislocation, Congenital
• Osteoarthritis

Intervention

Procedure:
• Anterior Minimally Invasive Approach (AMIS)

Locations

Country	Name	City	State
Germany	St. Elisabeth Dillingen	Dillingen an der Donau	Bayern

Sponsors (1)

Lead Sponsor	Collaborator
Medacta International SA

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No