Knee OsteoarthritisNCT06555055
Trochlear Thickness and Its Effect on the Outcomes of Total Knee Arthroplasty
An observational study of Knee Osteoarthritis, run by Ibrahim barsoum at 1 site in Egypt.
Trial summary
Total knee arthroplasty (TKA ) is the gold standard treatment for advanced knee osteoarthritis. only 85% (75% to 92%) of patients with total knee arthroplasty are satisfied with their operations and 30% develops patellofemoral complications. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- CT trochlear thickness change
- How many people
- 87 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Sep 2022to 1 Jul 2024
- 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with primary knee osteoarthritis
Who may be able to join
- Advanced knee osteoarthritis in which total knee arthroplasty is indicated
Who cannot join
- Revision total knee arthroplasty
- Previous osteotomy around the knee
- Post traumatic knee arthritis
- Inflammatory knee arthritis
Trial locations and contacts
1 site in 1 country.
About this study
Total knee arthroplasty (TKA ) is the gold standard treatment for advanced knee osteoarthritis. only 85% (75% to 92%) of patients with total knee arthroplasty are satisfied with their operations and 30% develops patellofemoral complications.
Numerous biomechanical studies suggest that patellofemoral tracking is not always restored to physiological values, because the prosthetic trochlea may differ from the native trochlea. no study has been con-ducted to investigate the thickness of the trochlear groove and its effect on the outcome of Total knee replacement (TKR), So many people has different measurements of trochlear thickness which may affect Patellofemoral joint (PFJ) so knowing of native trochlear thickness in patients with KNEE Osteoarthritis (OA) can affect the outcomes of total knee arthroplasty.
Read the detailed description
Total knee arthroplasty is the gold standard treatment for advanced knee osteoarthritis. In spite of the great advance in the prosthesis design, surgical techniques and rehabilitation programs, only 85% (75% to 92%) of patients with total knee arthroplasty are satisfied with their operations and 30% develops patellofemoral complications. Patellofemoral complications after TKR are usually caused by multiple factors related to surgical technique (e.g., implant positioning and sizing, soft-tissue balancing, patellar resurfacing, etc.) and implant design (e.g., trochlear thickness, sagittal curvature, patellar component shape).
Numerous biomechanical studies suggest that patellofemoral tracking is not always restored to physiological values, because the prosthetic trochlea may differ from the native trochlea.
Theoretically decreasing of contact area distance of trochlea might increase the contact pressure in the patellofemoral joint. The increased contact pressure will elevate the stress in the subchondral bone of the patellofemoral joint, which is hypothesized to be a cause of patellofemoral pain.
A mechanical experiment was performed in an attempt to analyze the influence of thickening of the patella on the knee extension movement. The measurement show that anterior advancement of the extensor apparatus at the level of the patella gives a mechanical advantage, enabling the quadriceps to extend the knee with the use of less force. so increase thickness of patella affects the quadriceps function but no study has been shown the effect of trochlear thickness on quadriceps or patellofemoral joint.
Nonetheless, no study has been con-ducted to investigate the thickness of the trochlear groove and its effect on the outcome of TKR, So many people has different measurements of trochlear thickness which may affect PFJ so knowing of native trochlear thickness in patients with KNEE OA can affect the outcomes of total knee arthroplasty.
Preoperative and postoperative radiography (CT scan) can provide an adequate measurement of trochlear thickness which will help in understanding more about PFJ and its effect in the total knee replacement.
- Conditions
- Knee Osteoarthritis
- Being tested
- CT trochlear thickness change
- Keywords
- Knee Osteoarthritis, patellofemoral, TKA, Trochlear thickness
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT trochlear thickness changeOther
Preoperative and postoperative CT scan measuring trochlear thickness of PFJ was defined as distance from deepest part of trochlea and line tangential to the anterior aspect of the femoral cortex. It was assessed on the sagittal cuts.
CT images will be viewed using Sante DICOM viewer version 5.4.2 and image fusion will be done using Overlay multiple image software.
Two observers will measure the angles and the intraobserver and interobserver reliabilities will be assessed for consistency by the intraclass correlation coefficient (ICC) and reliability coefficient using the SPSS software
| Study group | Role | What they receive |
|---|---|---|
| trochlear thickness change | Radiological Assessment of trochlear thickness of PFJ in primary TKR by preoperative and postoperative CT scan. and observing Effects of Ct Different measures changes in trochlear thickness on short term TKR outcomes Receives: Other: CT trochlear thickness change |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional outcome
knee society score (KSS).
Measured: preoperative and six months postoperatively
Functional Outcome
Patellofemoral score (Barlett patellofemoral score).
Measured: preoperative and six months postoperatively
Functional Outcome
ROM
Measured: preoperative and six months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2024
- Study start30 Sep 2022
- Primary completion1 May 2024
- Study completion1 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Knee 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
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ibrahim barsoum
- Sponsor type
- University, hospital or other
- Collaborators
- Ain Shams University
- Responsible party
- Sponsor-investigator, Ibrahim barsoum, Ain Shams University
- Investigators
- Ibrahim B Anis, MS, Principal investigator, Ain Shams UniversityWael S Abd El Mageed, MD, Study director, Ain Shams UniversitySherif M El Sayed, MD, Study director, Ain Shams UniversityZeiad M Zakaria, MD, Study director, Ain Shams UniversityMohmed E Awad, MD, Study director, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06555055
- Sponsor's protocol ID
- Trochlear thickness in TKA
- Status last verified
- Aug 2024
- First submitted
- 14 Jul 2024
- Last updated
- 15 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Ranawat CS, Flynn WF Jr, Saddler S, Hansraj KK, Maynard MJ. Long-term results of the total condylar knee arthroplasty. A 15-year survivorship study. Clin Orthop Relat Res. 1993 Jan;(286):94-102.
PubMed 8425373Healy WL, Wasilewski SA, Takei R, Oberlander M. Patellofemoral complications following total knee arthroplasty. Correlation with implant design and patient risk factors. J Arthroplasty. 1995 Apr;10(2):197-201. doi: 10.1016/s0883-5403(05)80127-5.
PubMed 7798101Dejour H, Walch G, Neyret P, Adeleine P. [Dysplasia of the femoral trochlea]. Rev Chir Orthop Reparatrice Appar Mot. 1990;76(1):45-54. French.
PubMed 2140459
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trochlear Thickness and Its Effect on the Outcomes of Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT06555055
- Acronym / sponsor ID
- Trochlear thickness in TKA
- Conditions
- Knee Osteoarthritis
- Keywords
- Knee Osteoarthritis, patellofemoral, TKA, Trochlear thickness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Ibrahim barsoumUniversity, hospital or other
- Collaborators
- Ain Shams University
- Study start
- 30 Sep 2022 (actual)
- Primary completion
- 1 May 2024 (actual)
- Study completion
- 1 Jul 2024 (actual)
- First posted
- 15 Aug 2024 (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.
Total knee arthroplasty (TKA ) is the gold standard treatment for advanced knee osteoarthritis. only 85% (75% to 92%) of patients with total knee arthroplasty are satisfied with their operations and 30% develops patellofemoral complications.
Numerous biomechanical studies suggest that patellofemoral tracking is not always restored to physiological values, because the prosthetic trochlea may differ from the native trochlea. no study has been con-ducted to investigate the thickness of the trochlear groove and its effect on the outcome of Total knee replacement (TKR), So many people has different measurements of trochlear thickness which may affect Patellofemoral joint (PFJ) so knowing of native trochlear thickness in patients with KNEE Osteoarthritis (OA) can affect the outcomes of total knee arthroplasty.
Detailed description
Total knee arthroplasty is the gold standard treatment for advanced knee osteoarthritis. In spite of the great advance in the prosthesis design, surgical techniques and rehabilitation programs, only 85% (75% to 92%) of patients with total knee arthroplasty are satisfied with their operations and 30% develops patellofemoral complications. Patellofemoral complications after TKR are usually caused by multiple factors related to surgical technique (e.g., implant positioning and sizing, soft-tissue balancing, patellar resurfacing, etc.) and implant design (e.g., trochlear thickness, sagittal curvature, patellar component shape).
Numerous biomechanical studies suggest that patellofemoral tracking is not always restored to physiological values, because the prosthetic trochlea may differ from the native trochlea.
Theoretically decreasing of contact area distance of trochlea might increase the contact pressure in the patellofemoral joint. The increased contact pressure will elevate the stress in the subchondral bone of the patellofemoral joint, which is hypothesized to be a cause of patellofemoral pain.
A mechanical experiment was performed in an attempt to analyze the influence of thickening of the patella on the knee extension movement. The measurement show that anterior advancement of the extensor apparatus at the level of the patella gives a mechanical advantage, enabling the quadriceps to extend the knee with the use of less force. so increase thickness of patella affects the quadriceps function but no study has been shown the effect of trochlear thickness on quadriceps or patellofemoral joint.
Nonetheless, no study has been con-ducted to investigate the thickness of the trochlear groove and its effect on the outcome of TKR, So many people has different measurements of trochlear thickness which may affect PFJ so knowing of native trochlear thickness in patients with KNEE OA can affect the outcomes of total knee arthroplasty.
Preoperative and postoperative radiography (CT scan) can provide an adequate measurement of trochlear thickness which will help in understanding more about PFJ and its effect in the total knee replacement.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| trochlear thickness change | – | Other: CT trochlear thickness changeRadiological Assessment of trochlear thickness of PFJ in primary TKR by preoperative and postoperative CT scan. and observing Effects of Ct Different measures changes in trochlear thickness on short term TKR outcomes |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with primary knee osteoarthritis
Key inclusion criteria (1 listed)
- Advanced knee osteoarthritis in which total knee arthroplasty is indicated
Key exclusion criteria (4 listed)
- Revision total knee arthroplasty
- Previous osteotomy around the knee
- Post traumatic knee arthritis
- Inflammatory knee arthritis
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 |
|---|---|---|
| CT trochlear thickness changePreoperative and postoperative CT scan measuring trochlear thickness of PFJ was defined as distance from deepest part of trochlea and line tangential to the anterior aspect of the femoral cortex. It was assessed on the sagittal cuts. CT images will be viewed using Sante DICOM viewer version 5.4.2 and image fusion will be done using Overlay multiple image software. Two observers will measure the angles and the intraobserver and interobserver reliabilities will be assessed for consistency by the intraclass correlation coefficient (ICC) and reliability coefficient using the SPSS software | Other | trochlear thickness change |
Primary outcome
Functional outcome
Time frame: preoperative and six months postoperatively
knee society score (KSS).
Functional Outcome
Time frame: preoperative and six months postoperatively
Patellofemoral score (Barlett patellofemoral score).
Functional Outcome
Time frame: preoperative and six months postoperatively
ROM
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2024.
- Results publication: PubMed 8425373Ranawat CS, Flynn WF Jr, Saddler S, Hansraj KK, Maynard MJ. Long-term results of the total condylar knee arthroplasty. A 15-year survivorship study. Clin Orthop Relat Res. 1993 Jan;(286):94-102.
- Results publication: PubMed 7798101Healy WL, Wasilewski SA, Takei R, Oberlander M. Patellofemoral complications following total knee arthroplasty. Correlation with implant design and patient risk factors. J Arthroplasty. 1995 Apr;10(2):197-201. doi: 10.1016/s0883-5403(05)80127-5.
- Results publication: PubMed 2140459Dejour H, Walch G, Neyret P, Adeleine P. [Dysplasia of the femoral trochlea]. Rev Chir Orthop Reparatrice Appar Mot. 1990;76(1):45-54. French.
- 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.
Ibrahim B Anis, MS principal investigator
Ain Shams University
Wael S Abd El Mageed, MD study director
Ain Shams University
Sherif M El Sayed, MD study director
Ain Shams University
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 Osteoarthritis, run by Ibrahim barsoum at 1 site in Egypt.
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 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: finished, as of the sponsor's last update on 15 Aug 2024. 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 Egypt. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Functional outcome (time frame: preoperative and six months postoperatively). The study lists 3 primary outcomes in all. 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 NCT06555055, which also lists 3 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 15 Aug 2024.