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

NCT ID: NCT01041937

Last Updated: 2019-01-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

106 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-12-31

Study Completion Date

2011-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Osteoarthritis Post-traumatic Osteoarthritis Rheumatoid Arthritis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Cemented Tibia

Assessing the clinical outcomes of the different type of fixation

Group Type ACTIVE_COMPARATOR

Cemented Tibia

Intervention Type PROCEDURE

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

Group Type ACTIVE_COMPARATOR

Cementless Tibia

Intervention Type PROCEDURE

Assessing the clinical outcomes of the different type of fixation

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Cemented Tibia

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

Intervention Type PROCEDURE

Cementless Tibia

Assessing the clinical outcomes of the different type of fixation

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Stryker Trauma and Extremities

INDUSTRY

Sponsor Role collaborator

Washington University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

John Clohisy, MD

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Washington University School of Medicine

St Louis, Missouri, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Clohisy TKA trial-201102554

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Cemented vs Cementless Persona Keel RCT
NCT05630053 ACTIVE_NOT_RECRUITING NA
Uncemented Tritanium TKR vs Cemented Triathlon TKR
NCT04040764 ACTIVE_NOT_RECRUITING NA
10003 PRO Current Products
NCT01497730 COMPLETED
Intraarticular Antibiotic in TKA
NCT04297631 COMPLETED PHASE4
All-poly Versus Metal-backed
NCT04358601 ACTIVE_NOT_RECRUITING NA