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NCT Number: NCT01041937

Total Knee Arthroplasty (TKA) Cemented Versus Cementless Tibial Prosthesis Study

The primary purpose of TKA Randomized Clinical Trial- Cemented versus Cementless Tibial Prosthesis Study will determine whether there is a significant difference in patient-reported and measured clinical outcomes (e.g. pain, function, length of recovery, and patient satisfaction) between subjects treated with a cementless tibial prosthesis (the cementless group) and those treated with cemented tibial prosthesis (the cement group) over the first two postoperative years. Radiographs will be assessed before surgery and at established post-operative intervals to determine if there are any significant differences between patients in the two groups and to assess the influence of component fixation on radiographic stability over time. Complication and revision rates will also be assessed for comparison.

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Key information

Conditions

Osteoarthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Post-traumatic Osteoarthritis Rheumatic Diseases Rheumatoid Arthritis Skin and Connective Tissue Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • BMI less than <35
  • Normal neurological function
  • Primary total knee arthroplasty (Pre operative Medial Knee Patient)
  • Patient age ≤ 70 years old

Exclusion criteria

  • Revision surgery
  • History of joint sepsis
  • Recent systemic corticosteroids (< 2 months prior to procedure)
  • Primary or secondary carcinoma in the last five years
  • Post operative renal transplant
  • Psychosocial disorders limiting rehabilitation
  • Previous intraarticular knee fracture
  • Over 20° valgus or varus deformity
  • Extension loss over 20°
  • Unsuitable for cruciate- substituting arthroplasty
  • Unsuitable for cementless fixation of the tibial component
  • Need for augmentation wedges or bone graft
  • Previous proximal tibial osteotomy

Treatment and study plan

Cemented Tibia

Procedure

Total knee arthroplasty with cemented or cemented tibia, and post operative clinical outcome tracking

Cementless Tibia

Procedure

Assessing the clinical outcomes of the different type of fixation

Primary outcomes

  1. To use clinical outcome measures to assess for differences in patient function, quality of life and satisfaction between patients who have tibial component placement with either a cemented or a cementless technique

    Time frame: 2014

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

  • Stryker Trauma and Extremities

Registry information

Official study title

Total Knee Arthroplasty Randomized Clinical Trial- Cemented vs. Cementless Tibial Prosthesis Study

Acronym: TKA

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Jan 5, 2010
Registry last updated
Jan 8, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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