Osteoarthritis, KneeNCT05998538
Patients With Higher BMI Produces More Postoperative Drainage Volume and Length of Stay in Cross-Sectional Study
An observational study of Osteoarthritis, Knee, run by Universitas Indonesia at 1 site in Indonesia.
Trial summary
Partial knee arthroplasty theoretically produces less blood loss compared to total knee arthroplasty (TKA) due to a lesser invasive procedure. Medial unicompartmental knee arthroplasty (UKA) is the most common partial knee arthroplasty performed due used due to the most commonly impacted medial knee. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Knee Replacement
- Type of treatment
- Surgery or procedure
- How many people
- 120 participants
- Where
- 1 siteIndonesia
- Study dates
- 23 Dec 2019to 7 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: medical records of patients who underwent primary TKA and UKA between December 2019 and October 2022
Who may be able to join
- grade 4 Osteoarthritis
Who cannot join
- previous trauma
- infection
- blood coagulation disorder
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Patients With Higher BMI Produces More Postoperative Drainage Volume and Longer Length of Stay in Cross-Sectional Study: a Comparison of Total vs Partial Knee Arthroplasty
Partial knee arthroplasty theoretically produces less blood loss compared to total knee arthroplasty (TKA) due to a lesser invasive procedure. Medial unicompartmental knee arthroplasty (UKA) is the most common partial knee arthroplasty performed due used due to the most commonly impacted medial knee. This study compared the postoperative drainage volume and length of stay (LOS) of TKA vs UKA and evaluated its comparison with patient characteristics.
Read the detailed description
Theoretically, UKA will produce less blood loss due to a shorter skin incision, quadriceps sparing muscle approach, persistence of cruciate ligaments, and less femorotibial dislocation.7 However, studies investigating drainage volume in UKA are still limited. In this study, we compared the drainage volume of patients undergoing TKA vs UKA and evaluated several parameters that contributed the production. This study has not received any funding or grant.
- Conditions
- Osteoarthritis, Knee
- Being tested
- Knee Replacement
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Knee ReplacementProcedure or surgery
Total vs Partial Knee Replacement
| Study group | Role | What they receive |
|---|---|---|
| TKA (Total Knee Arthroplasty) procedure | Total Knee Arthroplasty Receives: Procedure: Knee Replacement | |
| UKA (Uni Knee Arthroplasty) procedure | Uni Knee Arthroplasty Receives: Procedure: Knee Replacement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Drainage Volume
total drainage volume
Measured: 3-5 days post op
Secondary outcomes (1)
LOS
length of stay
Measured: pre-op until drainage removed, 3-6 days post op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2023
- Study start23 Dec 2019
- Primary completion21 Oct 2022
- Study completion7 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe 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 crossover
- Time perspective
- Retrospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ludwig Andre Pontoh, Universitas Indonesia
- Investigators
- Ismail H Dilogo, Prof, Study director, Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05998538
- Sponsor's protocol ID
- 23082020
- Status last verified
- Aug 2023
- First submitted
- 9 Aug 2023
- Last updated
- 21 Aug 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 21 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patients With Higher BMI Produces More Postoperative Drainage Volume and Longer Length of Stay in Cross-Sectional Study: a Comparison of Total vs Partial Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT05998538
- Acronym / sponsor ID
- 23082020
- Conditions
- Osteoarthritis, Knee
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 23 Dec 2019 (actual)
- Primary completion
- 21 Oct 2022 (actual)
- Study completion
- 7 Dec 2022 (actual)
- First posted
- 21 Aug 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.
Partial knee arthroplasty theoretically produces less blood loss compared to total knee arthroplasty (TKA) due to a lesser invasive procedure. Medial unicompartmental knee arthroplasty (UKA) is the most common partial knee arthroplasty performed due used due to the most commonly impacted medial knee. This study compared the postoperative drainage volume and length of stay (LOS) of TKA vs UKA and evaluated its comparison with patient characteristics.
Detailed description
Theoretically, UKA will produce less blood loss due to a shorter skin incision, quadriceps sparing muscle approach, persistence of cruciate ligaments, and less femorotibial dislocation.7 However, studies investigating drainage volume in UKA are still limited. In this study, we compared the drainage volume of patients undergoing TKA vs UKA and evaluated several parameters that contributed the production. This study has not received any funding or grant.
Study design
- Observational model
- Case crossover
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TKA (Total Knee Arthroplasty) procedure | – | Procedure: Knee ReplacementTotal Knee Arthroplasty |
| UKA (Uni Knee Arthroplasty) procedure | – | Procedure: Knee ReplacementUni Knee Arthroplasty |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- medical records of patients who underwent primary TKA and UKA between December 2019 and October 2022
Key inclusion criteria (1 listed)
- grade 4 Osteoarthritis
Key exclusion criteria (3 listed)
- previous trauma
- infection
- blood coagulation disorder
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 |
|---|---|---|
| Knee ReplacementTotal vs Partial Knee Replacement | Procedure or surgery | TKA (Total Knee Arthroplasty) procedure, UKA (Uni Knee Arthroplasty) procedure |
Primary outcome
Drainage Volume
Time frame: 3-5 days post op
total drainage volume
1 secondary outcome
LOS
Time frame: pre-op until drainage removed, 3-6 days post op
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 21 Aug 2023.
- 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.
Ismail H Dilogo, Prof study director
Universitas Indonesia
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 Osteoarthritis, Knee, run by Universitas Indonesia at 1 site in Indonesia.
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 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: finished, as of the sponsor's last update on 21 Aug 2023. 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 Indonesia. 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?
Drainage Volume (time frame: 3-5 days post op). 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 21 Aug 2023.