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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 study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01285843
First Posted: January 28, 2011
Last Update Posted: October 20, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Medacta International SA
  Purpose
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.

Condition Intervention
Osteoarthritis Arthritis Avascular Necrosis Fracture of the Femoral Neck or Head Congenital Hip Dysplasia Procedure: Anterior Minimally Invasive Approach (AMIS)

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Medacta International SA:

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. [ Time Frame: 0-12 months ]

Secondary Outcome Measures:
  • 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.


  • 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.

  • 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.


Enrollment: 40
Study Start Date: September 2010
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Quadra Group Procedure: Anterior Minimally Invasive Approach (AMIS)
Active Comparator: AMIStem Group Procedure: Anterior Minimally Invasive Approach (AMIS)

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01285843


Locations
Germany
St. Elisabeth Dillingen
Dillingen an der Donau, Bayern, Germany, 89407
Sponsors and Collaborators
Medacta International SA
Investigators
Principal Investigator: Martin Nolde, Dr. Med. DGOOC; BVO; BVASK
  More Information

ClinicalTrials.gov Identifier: NCT01285843     History of Changes
Other Study ID Numbers: P01.004.14
First Submitted: January 26, 2011
First Posted: January 28, 2011
Results First Submitted: August 27, 2014
Results First Posted: September 15, 2014
Last Update Posted: October 20, 2016
Last Verified: July 2011

Additional relevant MeSH terms:
Osteoarthritis
Necrosis
Hip Dislocation
Hip Dislocation, Congenital
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Pathologic Processes
Joint Dislocations
Bone Diseases
Wounds and Injuries
Hip Injuries
Musculoskeletal Abnormalities
Congenital Abnormalities