Roentgen Stereophotogrammetric Analysis (RSA) Trial Comparing Trabecular Metal Monoblock and Modular Tibial Components

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Dalhousie University
Sponsor:
Collaborator:
Zimmer, Inc.
Information provided by (Responsible Party):
Michael Dunbar, Dalhousie University
ClinicalTrials.gov Identifier:
NCT01180595
First received: August 11, 2010
Last updated: March 28, 2014
Last verified: March 2014

August 11, 2010
March 28, 2014
February 2011
July 2014   (final data collection date for primary outcome measure)
micromotion of tibial component as measured with RSA [ Time Frame: 2 years postoperative ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01180595 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Roentgen Stereophotogrammetric Analysis (RSA) Trial Comparing Trabecular Metal Monoblock and Modular Tibial Components
Randomized Control Study Using Roentgen Stereophotogrammetric Analysis (RSA) to Compare the Fixation of the Trabecular Metal Monoblock and the Trabecular Metal Modular Total Knee Arthroplasties

Total knee replacement is an effective option for treating chronic knee conditions that cause pain and functional impairment. Significant improvements in quality of life, as measured by both disease specific and generic quality of life measures have been well documented. Carefully monitored introduction of new implant designs through small, randomized trials using radiostereometric analysis (RSA) is gaining support. RSA is a radiographic technique that uses small tantalum balls implanted into the patient's bone to measure micromotion (<1 mm) at the bone - implant interface, something which is not possible to do reliably using regular x-ray techniques. The amount of micromotion that occurs within 2 years of surgery can be used to predict the long term survival of knee replacements. This provides a method for detecting inferior implant designs using only a small number of patients before release of these products into large clinical trials.

The study purpose is to utilize RSA to compare the migration patterns of the Trabecular Metal(TM) Monoblock and the TM Modular Total Knee Arthroplasties during the first two postop years and to determine what proportion of cases achieve adequate fixation. Secondary outcome measures will be recorded to quantify changes in functional status of subjects after surgery and bone mineral density will be monitored to quantify any changes 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.

Null Hypothesis: There is no significant difference in micromotion patterns of the TM arthroplasty components of the monoblock design and the modular design.

Alternative Hypothesis: There are significant differences in micromotion patterns between the tibial components of the monoblock design and the modular design.

This is a consecutive sample randomized control trial of patients undergoing total knee arthroplasty with the TM Monoblock and TM Modular Knee Arthroplasty systems utilizing RSA to identify the migration patterns of the tibial components of the implant. DEXA scanning will also be conducted to determine changes in the bone mineral density adjacent to the implant. Health status and functional outcome measures will be recorded to quantify functional status of subjects before surgery and at each follow-up interval. Gait will be monitored and analyzed preoperatively and postoperatively throughout the duration of the trial.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Osteoarthritis
  • Device: Trabecular Metal Modular Tibial Total Knee Component
    The modular design of the Trabecular Metal Total Knee allows for increased options for physicians however, it is not clear how this modular feature will affect fixation since it may compromise some of the advantages of the original TM Monoblock tibial component.
  • Device: Trabecular Metal Monoblock Tibial Total Knee Component
  • Modular
    Trabecular Metal Modular Tibial Total Knee Component
    Intervention: Device: Trabecular Metal Modular Tibial Total Knee Component
  • Monoblock
    Trabecular Metal Monoblock Tibial Total Knee Component
    Intervention: Device: Trabecular Metal Monoblock Tibial Total Knee Component
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
September 2014
July 2014   (final data collection date for primary outcome measure)

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
Both
21 Years to 80 Years
No
Canada
 
NCT01180595
CDHA-RS/2011-010
No
Michael Dunbar, Dalhousie University
Dalhousie University
Zimmer, Inc.
Principal Investigator: Michael J Dunbar, MD PhD Dalhousie University and CDHA
Dalhousie University
March 2014

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