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

This study has been completed.
Sponsor:
Collaborator:
Wright Medical Technology
Information provided by (Responsible Party):
Michael Dunbar, Dalhousie University
ClinicalTrials.gov Identifier:
NCT00657956
First received: April 8, 2008
Last updated: March 28, 2014
Last verified: March 2014
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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 Dalhousie University:

Primary Outcome Measures:
  • micromotion of tibial component as measured with RSA [ Time Frame: 2 years postoperative ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Bone mineral density around the tibial component [ Time Frame: 2 years postoperative ] [ Designated as safety issue: No ]
  • Subjective health outcome questionnaires - SF36, WOMAC, Oxford12 knee, Pain and Catastrophizing Scale, Standardized comorbidity questionnaire [ Time Frame: 2 years postoperative ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   21 Years to 80 Years
Genders Eligible for Study:   Both
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
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: 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

No publications provided

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
Study First Received: April 8, 2008
Last Updated: March 28, 2014
Health Authority: Canada: Health Canada

Keywords provided by 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

ClinicalTrials.gov processed this record on July 23, 2014