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:
Information provided by:
Medacta International SA
ClinicalTrials.gov Identifier:
NCT01285843
First received: January 26, 2011
Last updated: September 9, 2014
Last verified: July 2011
  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
Endpoint Classification: Efficacy Study
Masking: 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Changes From Baseline in Patients' Function. Clinical Evaluation Using the Harris Hip Score [ Time Frame: 6 weeks, 6 months, 1 year ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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

Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT01285843     History of Changes
Other Study ID Numbers: P01.004.14
Study First Received: January 26, 2011
Results First Received: August 27, 2014
Last Updated: September 9, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Osteoarthritis
Hip Dislocation, Congenital
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Musculoskeletal Abnormalities
Congenital Abnormalities

ClinicalTrials.gov processed this record on October 16, 2014