- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07517614
Condylar Offset and Outcomes in Primary Total Knee Arthroplasty (OFFSET-TKA)
April 3, 2026 updated by: Baris Acar, SB Istanbul Education and Research Hospital
Prospective Evaluation of Posterior and Anterior Condylar Offset and Their Impact on Functional Outcomes in Primary Total Knee Arthroplasty
This prospective cohort study aims to evaluate the effect of posterior condylar offset (PCO) and anterior condylar offset (ACO) changes on functional outcomes after primary total knee arthroplasty (TKA).
Standardized imaging and clinical assessment protocols will be used to determine optimal PCO and ACO ranges associated with improved postoperative range of motion, patient-reported outcomes, and reduced anterior knee symptoms.
Study Overview
Status
Not yet recruiting
Conditions
Study Type
Observational
Enrollment (Estimated)
100
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
patients undergoing primary total knee arthroplasty for osteoarthiritis
Description
Inclusion Criteria:
- diagnosis of primary knee osteoarthiritis
- indication of knee arthroplasty
- 50-85 years
- ability t oprovide informed consent and comply with follow up
Exclusion Criteria:
- revision knee arthroplasty
- inflammatory arthritis
- severe corona deformity (>20 varus/valgus)
- previous knee surgery or fracture
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
Primary TKA Cohort
Participants undergoing primary total knee arthtoplasty for knee osteoarthiritis will be prospectively followed.
Patients will be evaluated based on postoperative changes in posterior condylar offset and anterior condylar offset.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Maximum Knee Flexion
Time Frame: 12 months postoperatively
|
maximum active knee flexion measured in degrees using a goniometer during clinical examination
|
12 months postoperatively
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Knee Society Score
Time Frame: 3,6,12 months postoperatively
|
The Knee Society Score (KSS) is a clinician-reported outcome measure consisting of two components: the Knee Score (pain, stability, and range of motion) and the Function Score (walking distance and stair climbing).
Each component ranges from 0 to 100, with a total possible score of 200.
Higher scores indicate better knee function and clinical outcomes.
|
3,6,12 months postoperatively
|
|
WOMAC score
Time Frame: 3,6,12 months postoperatively
|
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) is a patient-reported outcome measure assessing pain, stiffness, and physical function.
The total score ranges from 0 to 96, with higher scores indicating worse pain, stiffness, and functional limitation.
|
3,6,12 months postoperatively
|
|
Change in Anterior and Posterior Condylar Offset
Time Frame: preoperative graphy and postoperative 1st day graphy
|
difference between preoperative and postoperative 1st day anterior condylar offset mesaured on lateral knee radiographs
|
preoperative graphy and postoperative 1st day graphy
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Zhong Y, Deng Z, Gu C, Li M, Kang Y, Liao W, Zhang Z. The Optimal Variation Range of Posterior Condylar Offset Associated with Positive Clinical Outcomes of Primary Total Knee Arthroplasty: A Retrospective Analysis. Orthop Surg. 2024 Nov;16(11):2708-2713. doi: 10.1111/os.14183. Epub 2024 Aug 6.
- Xu W, Huang X, Liu J, Zhang Z, Chen Z, Xia T, Yan B, Xu Y. Sagittal parameters after primary TKA affecting knee joint function: a correlative analysis and predictive model construction. J Orthop Surg Res. 2026 Feb 9;21(1):193. doi: 10.1186/s13018-026-06707-5.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
May 1, 2026
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
July 1, 2027
Study Registration Dates
First Submitted
March 28, 2026
First Submitted That Met QC Criteria
April 3, 2026
First Posted (Actual)
April 8, 2026
Study Record Updates
Last Update Posted (Actual)
April 8, 2026
Last Update Submitted That Met QC Criteria
April 3, 2026
Last Verified
April 1, 2026
More Information
Terms related to this study
Other Study ID Numbers
- TKA-OFFSET-2026-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.