search
Back to results

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

Primary Purpose

Osteoarthritis, Arthritis, Avascular Necrosis

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Anterior Minimally Invasive Approach (AMIS)
Sponsored by
Medacta International SA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • St. Elisabeth Dillingen

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Quadra Group

AMIStem Group

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
January 26, 2011
Last Updated
August 26, 2016
Sponsor
Medacta International SA
search

1. Study Identification

Unique Protocol Identification Number
NCT01285843
Brief 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
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.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2011
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
September 2012 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Medacta International SA

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Arthritis, Avascular Necrosis, Fracture of the Femoral Neck or Head, Congenital Hip Dysplasia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Quadra Group
Arm Type
Active Comparator
Arm Title
AMIStem Group
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Anterior Minimally Invasive Approach (AMIS)
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
Changes From Baseline in Patients' Function. Clinical Evaluation Using the Harris Hip Score
Description
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.
Time Frame
6 weeks, 6 months, 1 year
Title
Changes From Baseline in Patient's Activity Level. Assessment Using the High Activity Arthroplasty Score.
Description
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.
Time Frame
6 months, 1 year
Title
Radiological Evaluation to Assess the Fixation and Stability of Femoral and Acetabular Components.
Description
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.
Time Frame
6 months, 1 year

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin Nolde, Dr. Med.
Organizational Affiliation
DGOOC; BVO; BVASK
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Elisabeth Dillingen
City
Dillingen an der Donau
State/Province
Bayern
ZIP/Postal Code
89407
Country
Germany

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs