Primary Gonarthrosis, BilateralNCT04353440
Association Between Sagittal Patellar Offset and Anterior Knee Pain in Total Knee Arthroplasty
An observational study of Primary Gonarthrosis, Bilateral and Knee Osteoarthritis, run by Bezmialem Vakif University.
Trial summary
The aim of this study to evaluate whether the position of the sagittal patellar offset is a predictive factor for anterior knee pain in subjects having undergone bilateral multiradius total knee replacement. Read more about this study
- Who is it for?
- Ages 50 to 100 years
- Conditions the study is for
- Primary Gonarthrosis, Bilateral, Knee Osteoarthritis, Knee Arthritis
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 23 Apr 2020to 23 Jul 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing total knee arthroplasty due to severe gonarthrosis
Who may be able to join
- Patients over 50 years of age with primary severe gonarthrosis who will undergo total knee replacement
Who cannot join
- Patients with severe gonarthrosis, with a history of malignancy, with severe extraarticular deformity, with posttraumatic and septic arthritis sequel
About this study
Official title: Association Between Sagittal Patellar Offset and Anterior Knee Pain After Multiradius Total Knee Replacement.
The aim of this study to evaluate whether the position of the sagittal patellar offset is a predictive factor for anterior knee pain in subjects having undergone bilateral multiradius total knee replacement.
Read the detailed description
A prospective, observational study. A total of to 80 subjects requiring bilateral multiradius knee arthroplasty will be enrolled. Anterior femoral offset, femoral diameter and patellar offset will be measured by orthopaedic surgeons. In addition, Visual Analogue Scale Score, Oxford Knee Score, WOMAC, SF12 and SF36 will be evaluated postoperative in patients long-term follow up to see if there is a relationship between anterior femoral offset and anterior knee pain.In the direct lateral knee joint radiograph, the distance between the two parallel axis extending from both cortices of the femur is measured as "femoral diameter".The remaining length between the anterior axis and the maximum peak at the anterior of the prosthesis is considered as an "anterior femoral offset"[1]. Sagittal patellar offset defined by us as the ratio of the anterior femoral offset to the remaining distance between the maximum anterior point of the patella and the posterior vertex in the direct lateral knee joint radiography.
- Keywords
- total knee arthroplasty, anterior knee pain, sagittal patellar offset
- Medical subject headings
- Osteoarthritis, Knee
What is being measured
The primary outcome is the main question the study is designed to answer.
anterior patellar offset ratio
The distance between the anterior cortex of the femur and the maximum peak at the anterior of the prosthesis is considered as an "anterior femoral offset"[1].Sagittal patellar offset defined by us as the ratio of the anterior femoral offset to the remaining distance between the maximum anterior point of the patella and the posterior vertex in the direct lateral knee joint radiography.
Measured: minimum 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2020
- Study start23 Apr 2020 (estimated)
- Primary completion23 Apr 2025 (estimated)
- Study completion23 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Primary Gonarthrosis, BilateralStudies of the same condition, open and under way.
- More trials run by Bezmialem Vakif UniversityThe sponsor's other registered studies.
- 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
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Orkhan Aliyev, Bezmialem Vakif University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04353440
- Sponsor's protocol ID
- 19590
- Status last verified
- Apr 2020
- First submitted
- 16 Apr 2020
- Last updated
- 21 Apr 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Scott CEH, Clement ND, Yapp LZ, MacDonald DJ, Patton JT, Burnett R. Association Between Femoral Component Sagittal Positioning and Anterior Knee Pain in Total Knee Arthroplasty: A 10-Year Case-Control Follow-up Study of a Cruciate-Retaining Single-Radius Design. J Bone Joint Surg Am. 2019 Sep 4;101(17):1575-1585. doi: 10.2106/JBJS.18.01096.
PubMed 31483401
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Sagittal Patellar Offset and Anterior Knee Pain After Multiradius Total Knee Replacement.
- ClinicalTrials.gov ID
- NCT04353440
- Acronym / sponsor ID
- 19590
- Keywords
- total knee arthroplasty, anterior knee pain, sagittal patellar offset
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Study start
- 23 Apr 2020 (estimated)
- Primary completion
- 23 Apr 2025 (estimated)
- Study completion
- 23 Jul 2025 (estimated)
- First posted
- 20 Apr 2020 (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.
The aim of this study to evaluate whether the position of the sagittal patellar offset is a predictive factor for anterior knee pain in subjects having undergone bilateral multiradius total knee replacement.
Detailed description
A prospective, observational study. A total of to 80 subjects requiring bilateral multiradius knee arthroplasty will be enrolled. Anterior femoral offset, femoral diameter and patellar offset will be measured by orthopaedic surgeons. In addition, Visual Analogue Scale Score, Oxford Knee Score, WOMAC, SF12 and SF36 will be evaluated postoperative in patients long-term follow up to see if there is a relationship between anterior femoral offset and anterior knee pain.In the direct lateral knee joint radiograph, the distance between the two parallel axis extending from both cortices of the femur is measured as "femoral diameter".The remaining length between the anterior axis and the maximum peak at the anterior of the prosthesis is considered as an "anterior femoral offset"[1]. Sagittal patellar offset defined by us as the ratio of the anterior femoral offset to the remaining distance between the maximum anterior point of the patella and the posterior vertex in the direct lateral knee joint radiography.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 50 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing total knee arthroplasty due to severe gonarthrosis
Key inclusion criteria (1 listed)
- Patients over 50 years of age with primary severe gonarthrosis who will undergo total knee replacement
Key exclusion criteria (1 listed)
- Patients with severe gonarthrosis, with a history of malignancy, with severe extraarticular deformity, with posttraumatic and septic arthritis sequel
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
anterior patellar offset ratio
Time frame: minimum 1 year
The distance between the anterior cortex of the femur and the maximum peak at the anterior of the prosthesis is considered as an "anterior femoral offset"[1].Sagittal patellar offset defined by us as the ratio of the anterior femoral offset to the remaining distance between the maximum anterior point of the patella and the posterior vertex in the direct lateral knee joint radiography.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2020.
- Background: PubMed 31483401Scott CEH, Clement ND, Yapp LZ, MacDonald DJ, Patton JT, Burnett R. Association Between Femoral Component Sagittal Positioning and Anterior Knee Pain in Total Knee Arthroplasty: A 10-Year Case-Control Follow-up Study of a Cruciate-Retaining Single-Radius Design. J Bone Joint Surg Am. 2019 Sep 4;101(17):1575-1585. doi: 10.2106/JBJS.18.01096.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Primary Gonarthrosis, Bilateral and Knee Osteoarthritis, run by Bezmialem Vakif University.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 21 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
anterior patellar offset ratio (time frame: minimum 1 year). 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 NCT04353440, which also lists 1 linked publication.
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 21 Apr 2020.