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

NCT01041937 | Completed DMC

• 1 other identifier: Clohisy TKA trial-201102554
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Osteoarthritis; Post-traumatic Osteoarthritis; Rheumatoid Arthritis

Outcome Measures

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

  2014

Study Arms (2)

Cemented Tibia

ACTIVE COMPARATOR

Assessing the clinical outcomes of the different type of fixation

Procedure: Cemented Tibia

Cementless Tibia

ACTIVE COMPARATOR

Assessing the clinical outcomes of the different type of fixation

Procedure: Cementless Tibia

Interventions

Cemented Tibia PROCEDURE

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

Cemented Tibia

Cementless Tibia PROCEDURE

Assessing the clinical outcomes of the different type of fixation

Cementless Tibia

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Washington University School of Medicine: lead
• Stryker Trauma and Extremities: collaborator

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Conditions

Osteoarthritis; Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• John Clohisy, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2010
• First Posted: January 5, 2010
• Study Start: December 1, 2009
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: January 8, 2019

Record last verified: 2019-01

Locations

US (1)