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

Rheumatoid Arthritis Clinical Trial

— TKA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01041937
• Other study ID #: Clohisy TKA trial-201102554
• Status: Completed
• Phase: N/A
• Start date: December 2009
• Est. completion date: December 2011

Study information

• Verified date: January 2019
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Arthritis, Rheumatoid
• Osteoarthritis
• Post-traumatic Osteoarthritis
• Rheumatoid Arthritis

Intervention

Procedure:
• Cemented Tibia
Total knee arthroplasty with cemented or cemented tibia, and post operative clinical outcome tracking
• Cementless Tibia
Assessing the clinical outcomes of the different type of fixation

Locations

Country	Name	City	State
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Washington University School of Medicine	Wright Medical Technology

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		2014