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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

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ClinicalTrials.gov Identifier: NCT01285843
Recruitment Status : Completed
First Posted : January 28, 2011
Results First Posted : September 15, 2014
Last Update Posted : October 20, 2016
Sponsor:
Information provided by:
Medacta International SA

Tracking Information
First Submitted Date  ICMJE January 26, 2011
First Posted Date  ICMJE January 28, 2011
Results First Submitted Date  ICMJE August 27, 2014
Results First Posted Date  ICMJE September 15, 2014
Last Update Posted Date October 20, 2016
Study Start Date  ICMJE September 2010
Actual Primary Completion Date September 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 9, 2014)
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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: January 27, 2011)
Compare periprosthetic BMD in patients that have undergone a THA via the direct anterior approach receiving either a Quadra or AMIStem femoral component. [ Time Frame: 0-12 months ]
Change History Complete list of historical versions of study NCT01285843 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 9, 2014)
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: January 27, 2011)
  • Changes From Baseline in Patients' Function. Clinical Evaluation Using the Harris Hip Score [ Time Frame: 6 weeks, 6 months, 1 year ]
  • Changes From Baseline in Patient's Activity Level. Assessment Using the High Activity Arthroplasty Score. [ Time Frame: 6 months, 1 year ]
  • Radiological Evaluation to Assess the Fixation and Stability of Femoral and Acetabular Components. [ Time Frame: 6 months, 1 year ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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  ICMJE 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.
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Osteoarthritis
  • Arthritis
  • Avascular Necrosis
  • Fracture of the Femoral Neck or Head
  • Congenital Hip Dysplasia
Intervention  ICMJE Procedure: Anterior Minimally Invasive Approach (AMIS)
Study Arms  ICMJE
  • Active Comparator: Quadra Group
    Intervention: Procedure: Anterior Minimally Invasive Approach (AMIS)
  • Active Comparator: AMIStem Group
    Intervention: Procedure: Anterior Minimally Invasive Approach (AMIS)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 27, 2011)
40
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2012
Actual Primary Completion Date September 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01285843
Other Study ID Numbers  ICMJE P01.004.14
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Medacta International SA
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Martin Nolde, Dr. Med. DGOOC; BVO; BVASK
PRS Account Medacta International SA
Verification Date July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP