Arthroplasty, Replacement, KneeNCT03778463
Synovectomy in Primary Total Knee Arthrplasty
A study testing Synovectomy in people with Arthroplasty, Replacement, Knee and Synovectomy, run by Ain Shams University at 1 site in Egypt.
Trial summary
The aim of total knee arthroplasty is to achieve best patient functional outcomes, improve patient pain score and satisfaction. Synovial proliferation is a common finding in arthritic knees. Surgeons can't decide if synovectomy is a crucial step in the operation. Studies didn't prove the clear benefits of synovectomy. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Arthroplasty, Replacement, Knee, Synovectomy
- What is being tested?
- Synovectomy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- Dec 2018to Dec 2020
- Phase
- Interventional
- 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
Who may be able to join
- patients with primary osteoarthritis undergoing primary total knee arthroplasty
Who cannot join
- Inflammatory arthritis
- Revision knee arthroplasty
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Synovectomy Versus no Synovectomy in Primary Total Knee Arthrplasty : A Randomized Control Trial
The aim of total knee arthroplasty is to achieve best patient functional outcomes, improve patient pain score and satisfaction. Synovial proliferation is a common finding in arthritic knees. Surgeons can't decide if synovectomy is a crucial step in the operation. Studies didn't prove the clear benefits of synovectomy. We are aiming to perform a randomized clinical trial trying to reach the best evidence in that matter.
- Conditions
- Arthroplasty, Replacement, Knee, Synovectomy
- Being tested
- Synovectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SynovectomyOther
Removal of the synovium during total knee arthroplasty
| Study group | Role | What they receive |
|---|---|---|
| Synovectomy | Experimental | Not described Receives: Other: Synovectomy |
| No synovectomy | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional outcome scores. e.g. knee society score (KSS)
Measured: one year
knee pain e.g. visual analogue score (VAS) score
Measured: immediate postoperative
Health related quality of life e.g. short form (SF12) scale
Measured: one year
Revision rate
Measured: one year
Reoperation rate
Measured: one year
Range of motion
Measured: immediate postoperative
Range of motion
Measured: 6 month
Range of motion
Measured: One year
Secondary outcomes (5)
Postoperative blood loss
Measured: immediate postoperative
Postoperative hemoglobin level
gram/dl
Measured: immediate postoperative
Infection rate
Measured: in first three month
Wound complications
Measured: in first 3 months
Number of patients requiring transfusion
Measured: immediate postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2018
- Study startDec 2018 (estimated)
- Primary completionDec 2019 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthroplasty, Replacement, KneeStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Saeed Younis, Ain Shams University
- Investigators
- Ahmed Saeed Younis, Dr., Principal investigator, Ain Shams UniversityAmr Amal Elsayed Amin, Dr., Study director, Ain Shams UniversityWael Samir Osman, Professor, Study chair, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03778463
- Sponsor's protocol ID
- 12370677
- Status last verified
- Dec 2018
- First submitted
- 14 Dec 2018
- Last updated
- 19 Dec 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Synovectomy Versus no Synovectomy in Primary Total Knee Arthrplasty : A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT03778463
- Acronym / sponsor ID
- 12370677
- Conditions
- Arthroplasty, Replacement, Knee, Synovectomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- Dec 2018 (estimated)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 19 Dec 2018 (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 total knee arthroplasty is to achieve best patient functional outcomes, improve patient pain score and satisfaction. Synovial proliferation is a common finding in arthritic knees. Surgeons can't decide if synovectomy is a crucial step in the operation. Studies didn't prove the clear benefits of synovectomy. We are aiming to perform a randomized clinical trial trying to reach the best evidence in that matter.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Synovectomy | Experimental | Other: Synovectomy |
| No synovectomy | No intervention | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- patients with primary osteoarthritis undergoing primary total knee arthroplasty
Key exclusion criteria (2 listed)
- Inflammatory arthritis
- Revision knee arthroplasty
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 |
|---|---|---|
| SynovectomyRemoval of the synovium during total knee arthroplasty | Other | Synovectomy |
Primary outcome
Functional outcome scores. e.g. knee society score (KSS)
Time frame: one year
knee pain e.g. visual analogue score (VAS) score
Time frame: immediate postoperative
Health related quality of life e.g. short form (SF12) scale
Time frame: one year
Revision rate
Time frame: one year
Reoperation rate
Time frame: one year
Range of motion
Time frame: immediate postoperative
Range of motion
Time frame: 6 month
Range of motion
Time frame: One year
5 secondary outcomes
Postoperative blood loss
Time frame: immediate postoperative
Postoperative hemoglobin level
Time frame: immediate postoperative
Infection rate
Time frame: in first three month
Wound complications
Time frame: in first 3 months
Number of patients requiring transfusion
Time frame: immediate postoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2018.
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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.
Ahmed Saeed Younis, Dr. principal investigator
Ain Shams University
Amr Amal Elsayed Amin, Dr. study director
Ain Shams University
Wael Samir Osman, Professor study chair
Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Synovectomy in people with Arthroplasty, Replacement, Knee and Synovectomy, run by Ain Shams University 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 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 19 Dec 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmed Saeed Younis, Dr. (201012370677, ahmed.s.younis@med.asu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional outcome scores. e.g. knee society score (KSS) (time frame: one year). The study lists 8 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 19 Dec 2018.