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Roentgen Stereophotogrammetric Analysis (RSA) to Evaluate Fixation of Biofoam Advance Total Knee Arthroplasty Components

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00657956
First Posted: April 14, 2008
Last Update Posted: March 31, 2014
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.
Collaborator:
Wright Medical Technology
Information provided by (Responsible Party):
Michael Dunbar, Dalhousie University
  Purpose
Hip and knee replacement arthroplasty are profoundly successful operative interventions, however, some joint replacements do fail and the life expectancy of a hip or knee arthroplasty is finite. This fact has largely been responsible for the continued development of new devices and techniques for joint arthroplasty surgery. Unfortunately, the introduction of new technologies and devices is not a benign process, and even subtle changes to existing implants can have a disastrous effect on patient outcome. The fact that new technologies and devices can lead to poor results has led some authors to advocate a phased introduction of new technologies. A key component of the phased introduction approach advocates the use of roentgen stereophotogrammetric analysis (RSA) early in the testing process. RSA is a highly accurate radiographic technique developed in Lund, Sweden and has for some time been the gold standard in Europe for assessing the stability of implants within bone. The purpose of this study is to utilize RSA to elucidate the migration patterns of the foam metal backed Advance Knee Arthroplasty components during the first 2 years postoperatively and to determine in what proportion of cases adequate fixation is achieved. In addition outcome measures will be recorded to quantify changes in functional status of subjects after surgery and bone mineral density will be monitored to quantify bone in-growth around the implant. Migration patterns will be compared to results obtained from previous studies of uncemented and cemented total knee arthroplasty components conducted at this centre.

Condition Intervention
Osteoarthritis Device: Advance Biofoam porous metal backed tibial component with or without screw augmentation

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Prospective RCT Using Roentgen Stereophotogrammetric Analysis (RSA) to Evaluate Fixation of the Biofoam Advance Total Knee Arthroplasty Components With and Without Screw Augmentation

Resource links provided by NLM:


Further study details as provided by Michael Dunbar, Dalhousie University:

Primary Outcome Measures:
  • micromotion of tibial component as measured with RSA [ Time Frame: 2 years postoperative ]

Secondary Outcome Measures:
  • Bone mineral density around the tibial component [ Time Frame: 2 years postoperative ]
  • Subjective health outcome questionnaires - SF36, WOMAC, Oxford12 knee, Pain and Catastrophizing Scale, Standardized comorbidity questionnaire [ Time Frame: 2 years postoperative ]

Enrollment: 50
Study Start Date: April 2008
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Advance Biofoam porous metal backed tibial component with or without screw augmentation
    total knee arthroplasty tibial component that has a backing of porous titanium metal to facilitate bone in-growth
  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Symptomatic osteoarthritis of the knee indicating surgical intervention
  • Between the ages of 21 and 80 inclusive
  • Ability to give informed consent

Exclusion Criteria:

  • Significant co-morbidity affecting ability to ambulate
  • Flexion contracture greater than 15°
  • Extension lag greater than 10°
  • Tibial subluxation greater than 10 mm on standing AP radiograph
  • Prior arthroplasty, patellectomy or osteotomy with the affected knee
  • Lateral or medial collateral ligament instability (> 10° varus/valgus)
  • Leg length discrepancy greater than 10 mm
  • Active or prior infection
  • Morbid Obesity (BMI > 40)
  • Medical condition precluding major surgery
  • Severe osteoporosis or osteopenia
  • Neuromuscular impairment
  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): NCT00657956


Locations
Canada, Nova Scotia
Halifax Infirmary
Halifax, Nova Scotia, Canada, B3H 3A7
Sponsors and Collaborators
Dalhousie University
Wright Medical Technology
Investigators
Principal Investigator: Michael Gross, MD Dalhousie University
Study Director: Michael J Dunbar, MD PhD Dalhousie University
  More Information

Responsible Party: Michael Dunbar, MD, PhD, Dalhousie University
ClinicalTrials.gov Identifier: NCT00657956     History of Changes
Other Study ID Numbers: Dal07-02
CDHA-RS/2007-250 ( Other Identifier: Capital District Health Authority Halifax Nova Scotia )
First Submitted: April 8, 2008
First Posted: April 14, 2008
Last Update Posted: March 31, 2014
Last Verified: March 2014

Keywords provided by Michael Dunbar, Dalhousie University:
osteoarthritis
arthroplasty
knee joint
radiography
surgery
Bone Density
Outcome Assessment (Health Care)

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases