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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01041937

Acronym

TKA

Enrollment

106

Registered

2010-01-05

Start date

2009-12-31

Completion date

2011-12-31

Last updated

2019-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis, Post-traumatic Osteoarthritis, Rheumatoid Arthritis

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.

Interventions

PROCEDURECemented Tibia

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

PROCEDURECementless Tibia

Assessing the clinical outcomes of the different type of fixation

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026