Bilateral Total Knee Chronic Pain Following ArthroplastyNCT06079749
Risk of Chronic Post-surgical Pain After TKA
An observational study of Bilateral Total Knee Chronic Pain Following Arthroplasty, run by Gangnam Severance Hospital.
Trial summary
Chronic post-surgical pain (CPSP) is a common surgical complication. The role of timing in the development of CPSP after bilateral total knee arthroplasty (BTKA) is not well studied. We aimed to compare the occurrence of CPSP in patients who underwent simultaneous or staged BTKA without discharge between procedures. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Bilateral Total Knee Chronic Pain Following Arthroplasty
- What is being tested?
- Simultaneous BTKA and Staged BTKA
- Type of treatment
- Surgery or procedure
- How many people
- 403 participants
- Where
- No sites listed yet
- Study dates
- 12 Oct 2012to 31 Dec 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: From October 12, 2012 to December 2, 2021, patients who underwent bilateral or staged knee replacement surgery during a single hospitalization under Professor Lee Woo-seok at the Department of Orthopedics at Gangnam Severance Hospital due to bilateral knee arthritis.
Who may be able to join
- From October 12, 2012 to December 2, 2021, patients who underwent bilateral or staged knee replacement surgery during a single hospitalization under Professor Lee Woo-seok at the Department of Orthopedics at Gangnam Severance Hospital due to bilateral knee arthritis.
Who cannot join
- Patients whose post-operative pain information cannot be confirmed through outpatient visit records 1 year after surgery
- Those who have undergone surgery other than knee arthritis surgery within 1 year after surgery
About this study
Official title: Risk of Chronic Post-surgical Pain After Simultaneous Versus Staged Bilateral Knee Arthroplasty: A Retrospective Study With Propensity Score Matching
Chronic post-surgical pain (CPSP) is a common surgical complication. The role of timing in the development of CPSP after bilateral total knee arthroplasty (BTKA) is not well studied. We aimed to compare the occurrence of CPSP in patients who underwent simultaneous or staged BTKA without discharge between procedures.
- Being tested
- Simultaneous BTKA, Staged BTKA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simultaneous BTKAProcedure or surgery
Simultaneous BTKA
Staged BTKAProcedure or surgery
Staged BTKA
| Study group | Role | What they receive |
|---|---|---|
| Simultaneous BTKA | Simultaneous BTKA Receives: Procedure: Simultaneous BTKA | |
| Staged BTKA | Staged BTKA Receives: Procedure: Staged BTKA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chronic post-surgical pain at one year follow up
Numeric rating scale (0: no pain, 10: extreme pain)
Measured: at one year follow up after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2023
- Study start12 Oct 2012
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bilateral Total Knee Chronic Pain Following ArthroplastyStudies 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
- Retrospective
- Enrolment
- 403 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gangnam Severance Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Do-Hyeong Kim, Gangnam Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06079749
- Sponsor's protocol ID
- 3-2023-0080
- Status last verified
- Oct 2023
- First submitted
- 6 Oct 2023
- Last updated
- 12 Oct 2023
- Results posted
- 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 12 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk of Chronic Post-surgical Pain After Simultaneous Versus Staged Bilateral Knee Arthroplasty: A Retrospective Study With Propensity Score Matching
- ClinicalTrials.gov ID
- NCT06079749
- Acronym / sponsor ID
- 3-2023-0080
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 403 participants (actual)
- Lead sponsor
- Gangnam Severance HospitalUniversity, hospital or other
- Study start
- 12 Oct 2012 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 12 Oct 2023 (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.
Chronic post-surgical pain (CPSP) is a common surgical complication. The role of timing in the development of CPSP after bilateral total knee arthroplasty (BTKA) is not well studied. We aimed to compare the occurrence of CPSP in patients who underwent simultaneous or staged BTKA without discharge between procedures.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Simultaneous BTKA | – | Procedure: Simultaneous BTKASimultaneous BTKA |
| Staged BTKA | – | Procedure: Staged BTKAStaged BTKA |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- From October 12, 2012 to December 2, 2021, patients who underwent bilateral or staged knee replacement surgery during a single hospitalization under Professor Lee Woo-seok at the Department of Orthopedics at Gangnam Severance Hospital due to bilateral knee arthritis.
Key inclusion criteria (1 listed)
- From October 12, 2012 to December 2, 2021, patients who underwent bilateral or staged knee replacement surgery during a single hospitalization under Professor Lee Woo-seok at the Department of Orthopedics at Gangnam Severance Hospital due to bilateral knee arthritis.
Key exclusion criteria (2 listed)
- Patients whose post-operative pain information cannot be confirmed through outpatient visit records 1 year after surgery
- Those who have undergone surgery other than knee arthritis surgery within 1 year after 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 |
|---|---|---|
| Simultaneous BTKASimultaneous BTKA | Procedure or surgery | Simultaneous BTKA |
| Staged BTKAStaged BTKA | Procedure or surgery | Staged BTKA |
Primary outcome
Chronic post-surgical pain at one year follow up
Time frame: at one year follow up after surgery
Numeric rating scale (0: no pain, 10: extreme pain)
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 12 Oct 2023.
- Individual participant dataSharing planned: No
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 Bilateral Total Knee Chronic Pain Following Arthroplasty, run by Gangnam Severance 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 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: finished, as of the sponsor's last update on 12 Oct 2023. 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?
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?
Chronic post-surgical pain at one year follow up (time frame: at one year follow up after surgery). 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 12 Oct 2023.