Knee OsteoarthritisNCT03365271
The Post-operative Effect of Applying Drainage on Total Knee Arthroplasty
A study testing drainage and non-drainage in people with Knee Osteoarthritis, run by Peking University People's Hospital.
Trial summary
This multicenter clinical trial aims to investigate the exact effect of drainage use for osteoarthritis patients in total knee arthroplasty (TKA) on post-operative performance. Read more about this study
- Who is it for?
- Ages 50 to 70 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- drainage and non-drainage
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Feb 2018to Feb 2019
- 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 50 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ready to receive single-side TKA
- Be evaluated as ASA 1-2 degree before operation
Who cannot join
- coagulation disorder
- peripheral vessel diseases
- contraindication of surgery
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Study on the Post-operative Effect of Applying Drainage on Total Knee Arthroplasty
This multicenter clinical trial aims to investigate the exact effect of drainage use for osteoarthritis patients in total knee arthroplasty (TKA) on post-operative performance.
Read the detailed description
This is a multicenter,open-label randomized controlled trail. A total of 100 participants will receive same perioperative treatment schedule, and all surgeries will be carried out by the same surgeon. Among all the participants, 50 patients will be randomly assigned to the experiment group in which a drainage will be applied during the surgery, while another 50 patients will be randomly assigned to the control group without a drainage application in the surgery.Data on perioperative bleeding volume, swelling of lower extremities, pain score will be collected and analysed.
- Conditions
- Knee Osteoarthritis
- Being tested
- drainage, non-drainage
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
drainageProcedure or surgery
Applying a drain tube during TKA procedure
non-drainageProcedure or surgery
No drain tube will be applied during TKA procedure
| Study group | Role | What they receive |
|---|---|---|
| drainage | Experimental | A drainage will be applied in this group. Receives: Procedure: drainage |
| without drainage | Active comparator | Non-drainage will be applied in this group. Receives: Procedure: non-drainage |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change of bleeding volume in perioperative period
The difference between baseline Hct collected before operation and Hct collected one week after operation
Measured: before operation and one week after operation
Secondary outcomes (3)
Swelling of the lower extremities
perimeter of lower extremities before and after operation
Measured: one week after operation
Range of motion
Range of motion of the knee received operation
Measured: one week after operation
Pain
Use the Visual Analogue Scale to estimate the pain and its score ranges from 0 to 10. The higher the score is, the more severe pain the patient is feeling.
Measured: one week after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2017
- Study startFeb 2018 (estimated)
- Primary completionAug 2018 (estimated)
- Study completionFeb 2019 (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 Peking University People's 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lin Chutong, Peking University People's Hospital
- Investigators
- Jianhao Lin, MD, Principal investigator, arthritis clinic and research center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03365271
- Sponsor's protocol ID
- PUPHEMS
- Status last verified
- Dec 2017
- First submitted
- 25 Nov 2017
- Last updated
- 7 Dec 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Post-operative Effect of Applying Drainage on Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT03365271
- Acronym / sponsor ID
- PUPHEMS
- Conditions
- Knee Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- Feb 2018 (estimated)
- Primary completion
- Aug 2018 (estimated)
- Study completion
- Feb 2019 (estimated)
- First posted
- 7 Dec 2017 (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 multicenter clinical trial aims to investigate the exact effect of drainage use for osteoarthritis patients in total knee arthroplasty (TKA) on post-operative performance.
Detailed description
This is a multicenter,open-label randomized controlled trail. A total of 100 participants will receive same perioperative treatment schedule, and all surgeries will be carried out by the same surgeon. Among all the participants, 50 patients will be randomly assigned to the experiment group in which a drainage will be applied during the surgery, while another 50 patients will be randomly assigned to the control group without a drainage application in the surgery.Data on perioperative bleeding volume, swelling of lower extremities, pain score will be collected and analysed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| drainage | Experimental | Procedure: drainageA drainage will be applied in this group. |
| without drainage | Active comparator | Procedure: non-drainageNon-drainage will be applied in this group. |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Ready to receive single-side TKA
- Be evaluated as ASA 1-2 degree before operation
Key exclusion criteria (3 listed)
- coagulation disorder
- peripheral vessel diseases
- contraindication of surgery
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 |
|---|---|---|
| drainageApplying a drain tube during TKA procedure | Procedure or surgery | drainage |
| non-drainageNo drain tube will be applied during TKA procedure | Procedure or surgery | without drainage |
Primary outcome
The change of bleeding volume in perioperative period
Time frame: before operation and one week after operation
The difference between baseline Hct collected before operation and Hct collected one week after operation
3 secondary outcomes
Swelling of the lower extremities
Time frame: one week after operation
Range of motion
Time frame: one week after operation
Pain
Time frame: one week after operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2017.
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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.
Jianhao Lin, MD principal investigator
arthritis clinic and research center
Questions about this trial
What is this clinical trial studying?
A study testing drainage and non-drainage in people with Knee Osteoarthritis, run by Peking University People's 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 2 inclusion and 3 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 7 Dec 2017. 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 Chutong Lin (+86 15652930253, chutonglin@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change of bleeding volume in perioperative period (time frame: before operation and one week after operation). 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 7 Dec 2017.