Knee Arthritis OsteoarthritisOFFSET-TKANCT07517614
Condylar Offset and Outcomes in Primary Total Knee Arthroplasty
An observational study of Knee Arthritis Osteoarthritis, run by SB Istanbul Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
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). Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Knee Arthritis Osteoarthritis
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 May 2026to Jul 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients undergoing primary total knee arthroplasty for osteoarthiritis
Who may be able to join
- diagnosis of primary knee osteoarthiritis
- indication of knee arthroplasty
- 50-85 years
- ability t oprovide informed consent and comply with follow up
Who cannot join
- revision knee arthroplasty
- inflammatory arthritis
- severe corona deformity (>20 varus/valgus)
- previous knee surgery or fracture
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Knee Arthritis Osteoarthritis
- Keywords
- knee osteoarthiritis, anterior condylar offset, posterior condylar offset
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Maximum Knee Flexion
maximum active knee flexion measured in degrees using a goniometer during clinical examination
Measured: 12 months postoperatively
Secondary outcomes (3)
Knee Society Score
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.
Measured: 3,6,12 months postoperatively
WOMAC score
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.
Measured: 3,6,12 months postoperatively
Change in Anterior and Posterior Condylar Offset
difference between preoperative and postoperative 1st day anterior condylar offset mesaured on lateral knee radiographs
Measured: preoperative graphy and postoperative 1st day graphy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2026
- Study start20 May 2026
- Primary completionDec 2026 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Knee Arthritis OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SB Istanbul Education and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Baris Acar, SB Istanbul Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07517614
- Sponsor's protocol ID
- TKA-OFFSET-2026-01
- Acronym
- OFFSET-TKA
- Status last verified
- Apr 2026
- First submitted
- 28 Mar 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 39107882Xu 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.
PubMed 41656286
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of Posterior and Anterior Condylar Offset and Their Impact on Functional Outcomes in Primary Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT07517614
- Acronym / sponsor ID
- OFFSET-TKA / TKA-OFFSET-2026-01
- Conditions
- Knee Arthritis Osteoarthritis
- Keywords
- knee osteoarthiritis, anterior condylar offset, posterior condylar offset
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- SB Istanbul Education and Research HospitalUniversity, hospital or other
- Study start
- 20 May 2026 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 8 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients undergoing primary total knee arthroplasty for osteoarthiritis
Key inclusion criteria (4 listed)
- diagnosis of primary knee osteoarthiritis
- indication of knee arthroplasty
- 50-85 years
- ability t oprovide informed consent and comply with follow up
Key exclusion criteria (4 listed)
- revision knee arthroplasty
- inflammatory arthritis
- severe corona deformity (>20 varus/valgus)
- previous knee surgery or fracture
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Maximum Knee Flexion
Time frame: 12 months postoperatively
maximum active knee flexion measured in degrees using a goniometer during clinical examination
3 secondary outcomes
Knee Society Score
Time frame: 3,6,12 months postoperatively
WOMAC score
Time frame: 3,6,12 months postoperatively
Change in Anterior and Posterior Condylar Offset
Time frame: preoperative graphy and postoperative 1st day graphy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Background: PubMed 39107882Zhong 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.
- Background: PubMed 41656286Xu 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Knee Arthritis Osteoarthritis, run by SB Istanbul Education and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Knee Flexion (time frame: 12 months postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07517614, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.