Status:

COMPLETED

Trabecular Metal Mesh Tibial Monoblock RSA

Lead Sponsor:

Dalhousie University

Collaborating Sponsors:

Stryker Trauma and Extremities

Conditions:

Osteoarthritis

Eligibility:

All Genders

55-80 years

Phase:

NA

Brief Summary

Trabecular Metal(TM) is a relatively new technology and its use in knee replacement is quite different from the more conventional total knee replacement (arthroplastie). The aim of incorporating TMM i...

Detailed Description

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 (Malch...

Eligibility Criteria

Inclusion

  • Age between 55 and 80
  • Primary osteoarthritis of the knee
  • Mono-articular disease (Charnley Modified Type A)

Exclusion

  • Significant co-morbidity affecting ability to ambulate
  • Flexion contracture greater than 15°
  • Tibial subluxation greater than 10 mm on standing AP radiograph
  • Greater than 10° of varus or 15° of valgus
  • Extension lag greater than 10°
  • Lateral or medial collateral ligament instability (\> 10° varus/valgus)
  • Previous osteotomy about the knee
  • Previous arthroplasty of the knee
  • Previous patellectomy
  • Posterior cruciate ligament deficiency
  • Leg length discrepancy greater than 10 mm
  • Morbid obesity

Key Trial Info

Start Date :

July 1 2002

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

February 1 2007

Estimated Enrollment :

67 Patients enrolled

Trial Details

Trial ID

NCT00405379

Start Date

July 1 2002

End Date

February 1 2007

Last Update

April 10 2008

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Trabecular Metal Mesh Tibial Monoblock RSA | DecenTrialz