Knee OsteoarthritisNCT05477745
The Correlation Between Femoral Component Implanting Flexion Angle and Posterior Condyle Offset in Cruciate Retaining Total Knee Arthroplasty
An observational study of Knee Osteoarthritis, run by RenJi Hospital.
Trial summary
The main aim and scope is making measurement and comparison about the femoral component posterior offset under different femoral component implanting flexion angle in cruciate retaining total knee arthroplasty. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- total knee arthroplasty
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 29 Jul 2022to 22 Aug 2022
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All the patients were treated with primary total knee arthroplasty in Renji Hospital affiliated to Shanghai Jiaotong University School of Medicine.
Who may be able to join
- The patients undertaken the primary cruciate retaining total knee arthroplasty;
- using the curiate retaining total knee arthroplasty prothesis from Biomet and Smith\&Nephew;
- Complete surgery documents and radiologic data,such as standard X-ray postoperative both at antirior-posterior position and medial-lateral position(overlap of the medial and lateral femoral condyle).
Who cannot join
- The patients without standard X-ray postoperative both at antirior-posterior position and medial-lateral position(poor overlap of the medial and lateral femoral condyle);
- Complex primary total knee arthroplasty, using extra component such as trabecular metal,stem or et al.
Trial locations and contacts
No sites are listed yet.
About this study
The main aim and scope is making measurement and comparison about the femoral component posterior offset under different femoral component implanting flexion angle in cruciate retaining total knee arthroplasty. The results may identify the influence of the flexion component implanting flexion angle on the femoral component posterior offset.
- Conditions
- Knee Osteoarthritis
- Being tested
- total knee arthroplasty
- Keywords
- Sagittal flexion angle, Posterior femoral offset, Cruciate-retaining total knee arthroplasty
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
total knee arthroplastyProcedure or surgery
The surgeries were performed under general anesthesia. The medial parepatellar incision was introduced during the TKA. The femoral component size was selected according to the intro-operative measurement. The osteotomy was done according to the intramedullary guide and the cutting guide. After the proximal tibial osteotomy was finished, the cruciate-retaining Total Knee System was used. The lateral rotation of the femoral component was determined by the gap-balancing technique.
| Study group | Role | What they receive |
|---|---|---|
| The group that the sagittal flexion angle of the femoral component less than 4° | The patients' knees were taken on the X-ray examination after the total knee arthroplasty on the medial-lateral position. The flexion (positive degree) or extension (negative degree) angle of the femoral component according to the anterior femoral cortex was measured. The patients with the sagittal flexion angle of the femoral component less than 4° were categorized into this group. Receives: Procedure: total knee arthroplasty | |
| The group that the sagittal flexion angle of the femoral component over 4° | The patients' knees were taken on the X-ray examination after the total knee arthroplasty on the medial-lateral position. The flexion (positive degree) or extension (negative degree) angle of the femoral component according to the anterior femoral cortex was measured. The patients with the sagittal flexion angle of the femoral component over 4° were categorized into this group. Receives: Procedure: total knee arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Posterior Femoral Offset
The posterior femoral offset was defined as the maximal thickness of the posterior condyle projecting posteriorly to a straight line drawn as the extension of the posterior femoral shaft cortex on the medial-lateral position of the X-ray examination.
Measured: 1 week after the surgery
Posterior Femoral Offset Ratio
The posterior femoral offset ratio was defined as the maximal thickness of the posterior condyle projecting posteriorly to a straight line drawn as the extension of the posterior femoral shaft cortex, divided by the maximal thickness of the posterior condyle projecting posterior to a straight line drawn as the extension of the anterior femoral shaft contex on the medial-lateral position of the X-ray examination.
Measured: 1 week after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2022
- Study start29 Jul 2022 (estimated)
- Primary completion15 Aug 2022 (estimated)
- Study completion22 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by RenJi HospitalThe 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lin Du, Study chair, RenJi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05477745
- Sponsor's protocol ID
- IIT-2022-0048
- Status last verified
- Jul 2022
- First submitted
- 25 Jul 2022
- Last updated
- 28 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Correlation Between Femoral Component Implanting Flexion Angle and Posterior Condyle Offset in Cruciate Retaining Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT05477745
- Acronym / sponsor ID
- IIT-2022-0048
- Conditions
- Knee Osteoarthritis
- Keywords
- Sagittal flexion angle, Posterior femoral offset, Cruciate-retaining total knee arthroplasty
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- 29 Jul 2022 (estimated)
- Primary completion
- 15 Aug 2022 (estimated)
- Study completion
- 22 Aug 2022 (estimated)
- First posted
- 28 Jul 2022 (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 main aim and scope is making measurement and comparison about the femoral component posterior offset under different femoral component implanting flexion angle in cruciate retaining total knee arthroplasty. The results may identify the influence of the flexion component implanting flexion angle on the femoral component posterior offset.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The group that the sagittal flexion angle of the femoral component less than 4° | – | Procedure: total knee arthroplastyThe patients' knees were taken on the X-ray examination after the total knee arthroplasty on the medial-lateral position. The flexion (positive degree) or extension (negative degree) angle of the femoral component according to the anterior femoral cortex was measured. The patients with the sagittal flexion angle of the femoral component less than 4° were categorized into this group. |
| The group that the sagittal flexion angle of the femoral component over 4° | – | Procedure: total knee arthroplastyThe patients' knees were taken on the X-ray examination after the total knee arthroplasty on the medial-lateral position. The flexion (positive degree) or extension (negative degree) angle of the femoral component according to the anterior femoral cortex was measured. The patients with the sagittal flexion angle of the femoral component over 4° were categorized into this group. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All the patients were treated with primary total knee arthroplasty in Renji Hospital affiliated to Shanghai Jiaotong University School of Medicine.
Key inclusion criteria (3 listed)
- The patients undertaken the primary cruciate retaining total knee arthroplasty;
- using the curiate retaining total knee arthroplasty prothesis from Biomet and Smith\&Nephew;
- Complete surgery documents and radiologic data,such as standard X-ray postoperative both at antirior-posterior position and medial-lateral position(overlap of the medial and lateral femoral condyle).
Key exclusion criteria (2 listed)
- The patients without standard X-ray postoperative both at antirior-posterior position and medial-lateral position(poor overlap of the medial and lateral femoral condyle);
- Complex primary total knee arthroplasty, using extra component such as trabecular metal,stem or et al.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| total knee arthroplastyThe surgeries were performed under general anesthesia. The medial parepatellar incision was introduced during the TKA. The femoral component size was selected according to the intro-operative measurement. The osteotomy was done according to the intramedullary guide and the cutting guide. After the proximal tibial osteotomy was finished, the cruciate-retaining Total Knee System was used. The lateral rotation of the femoral component was determined by the gap-balancing technique. | Procedure or surgery | The group that the sagittal flexion angle of the femoral component less than 4°, The group that the sagittal flexion angle of the femoral component over 4° |
Primary outcome
Posterior Femoral Offset
Time frame: 1 week after the surgery
The posterior femoral offset was defined as the maximal thickness of the posterior condyle projecting posteriorly to a straight line drawn as the extension of the posterior femoral shaft cortex on the medial-lateral position of the X-ray examination.
Posterior Femoral Offset Ratio
Time frame: 1 week after the surgery
The posterior femoral offset ratio was defined as the maximal thickness of the posterior condyle projecting posteriorly to a straight line drawn as the extension of the posterior femoral shaft cortex, divided by the maximal thickness of the posterior condyle projecting posterior to a straight line drawn as the extension of the anterior femoral shaft contex on the medial-lateral position of the X-ray examination.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2022.
- Individual participant dataSharing planned: No
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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.
Lin Du study chair
RenJi Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Knee Osteoarthritis, run by RenJi Hospital.
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 3 inclusion and 2 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 28 Jul 2022. 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?
Contact Lin Du (86-13817371926, sato316@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Posterior Femoral Offset (time frame: 1 week after the surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Jul 2022.