Knee Osteoarthritis (Knee OA)NCT07302724
Drain Removal Before Versus After CPM in Primary Total Knee Arthroplasty
A study testing Drain Removal Before CPM and Drain Removal After CPM in people with Knee Osteoarthritis (Knee OA) and Total Knee Anthroplasty, run by Ankara Etlik City Hospital at 1 site in Turkey (Türkiye).
Trial summary
The aim of this prospective randomized controlled study was to determine whether the timing of drain removal in relation to continuous passive motion (CPM) application influences postoperative residual hematoma formation following primary total knee arthroplasty (TKA). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Knee Osteoarthritis (Knee OA), Total Knee Anthroplasty, Postoperative Hematoma
- What is being tested?
- Drain Removal Before CPM and Drain Removal After CPM
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jun 2025to 30 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older
- Undergoing primary unilateral total knee arthroplasty (TKA) for end-stage knee osteoarthritis
- Able to provide written informed consent
- Able to comply with scheduled postoperative follow-up assessments
Who cannot join
- Revision total knee arthroplasty
- Previous infection in the index knee
- Inflammatory arthropathy
- Neuromuscular disorders affecting lower extremity function
- Inability to attend follow-up visits
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Drain Removal Before Versus After Continuous Passive Motion in Primary Total Knee Arthroplasty: Impact on Residual Hematoma in a Prospective Controlled Study
The aim of this prospective randomized controlled study was to determine whether the timing of drain removal in relation to continuous passive motion (CPM) application influences postoperative residual hematoma formation following primary total knee arthroplasty (TKA). Our primary hypothesis was that removing the drain after initiating CPM would result in less residual hematoma, as CPM-induced intra-articular fluid and blood mobilization would be evacuated through the drain before its removal, thereby reducing postoperative fluid accumulation.
Read the detailed description
This prospective, parallel-group interventional study was conducted at a single tertiary care center between June 2025 and December 2025 following approval by the institutional ethics committee. All patients provided written informed consent prior to participation.
A total of 104 consecutive patients undergoing primary unilateral total knee arthroplasty (TKA) were enrolled during the study period. During follow-up, four patients from each group were lost, leaving 96 patients available for final analysis.
Participants were allocated into two groups using a sequential alternating allocation method (2-1-2-1 sequence). Although not computer-generated, this prospective allocation approach ensured balanced group sizes throughout enrollment. Due to the nature of the intervention, allocation concealment and blinding were not applied.
All surgical procedures were performed by senior arthroplasty surgeons using a standardized medial parapatellar approach under spinal anesthesia. A uniform perioperative protocol was applied to all patients, including antibiotic prophylaxis with intravenous cefazolin and thromboembolism prophylaxis with low-molecular-weight heparin. All procedures were performed under tourniquet control. A single standard intra-articular hemovac drain of identical size and model was placed in all patients prior to wound closure.
Postoperatively, all patients underwent a standardized continuous passive motion (CPM) protocol approximately 24 hours after surgery. CPM was applied for 1 hour with a motion range of 0-90 degrees under supervision of the physiotherapy team.
The only interventional difference between study groups was the timing of drain removal in relation to CPM therapy. In the first group, the hemovac drain was removed immediately before initiation of CPM. In the second group, the drain was removed immediately after completion of the CPM session. All other perioperative care and rehabilitation protocols were identical between groups.
- Being tested
- Drain Removal Before CPM, Drain Removal After CPM
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drain Removal Before CPMProcedure or surgery
Hemovac drain removal performed approximately 24 hours after primary TKA, immediately before a standardized 1-hour CPM session (0-90°). All other surgical, perioperative, and rehabilitation protocols are identical across study arms.
Drain Removal After CPMProcedure or surgery
A standardized 1-hour CPM session at 0-90° is administered approximately 24 hours after primary TKA. The hemovac drain is removed immediately after completion of the CPM session. All other surgical, perioperative, and rehabilitation protocols are identical across study arms.
| Study group | Role | What they receive |
|---|---|---|
| Drain Removal Before CPM | Other | The hemovac drain is removed approximately 24 hours after surgery, immediately before a standardized 1-hour CPM session performed at 0-90° flexion. All other perioperative and rehabilitation protocols are identical between groups. Receives: Procedure: Drain Removal Before CPM |
| Drain Removal After CPM | Other | Patients undergo a standardized 1-hour CPM session at 0-90° flexion approximately 24 hours after surgery. The hemovac drain is removed immediately after completion of the CPM session. All other perioperative and rehabilitation protocols are identical between groups. Receives: Procedure: Drain Removal After CPM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Residual Hematoma Formation
Residual hematoma formation assessed by knee circumference measurements at the level of the superior pole of the patella. Circumference is measured on both the operated and contralateral knees. The difference from baseline and between-group differences are evaluated.
Measured: Preoperative; Postoperative Day 2; Day 14; Day 28
Secondary outcomes (6)
Wound Healing
Wound healing assessed using the Surgical Wound Aspect Score (SWAS), a clinical scoring system evaluating wound characteristics such as swelling (minimum = 0 points, maximum = 2 points), erythema (minimum = 0 points, maximum = 2 points), ecchymosis (minimum = 0 points, maximum = 2 points), blood drainage (minimum = 0 points, maximum = 2 points), and blisters (minimum = 0 points, maximum = 2 points). Finally, a score of 0 points (the best) to 10 points (the worst) was obtained by adding the results of these 5 parameters.
Measured: Postoperative Day 2; Day 14
Range of Motion (ROM)
Goniometric measurement of knee flexion and extension on the operated limb. Differences from baseline and between groups are evaluated across postoperative follow-up visits.
Measured: Preoperative; Postoperative Day 2; Day 14; Day 28
Pain Assessment
Pain intensity assessed using the Visual Analog Scale (VAS), ranging from 0 to 10, where 0 represents no pain and 10 represents the worst imaginable pain. Higher scores indicate greater pain severity.
Measured: Preoperative; Postoperative Day 14; Day 28
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Functional outcome assessed using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), ranging from 0 to 96, where higher scores indicate worse pain, stiffness, and functional limitation.
Measured: Preoperative; Postoperative Day 28
Lysholm Knee Score
Knee function assessed using the Lysholm Knee Score, ranging from 0 to 100, where higher scores indicate better knee function.
Measured: Preoperative; Postoperative Day 28
Oxford Knee Score
Patient-reported knee function assessed using the Oxford Knee Score, ranging from 0 to 48, where higher scores indicate better knee function.
Measured: Preoperative; Postoperative Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2025
- Study start15 Jun 2025
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee Osteoarthritis (Knee OA)Studies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two-arm prospective parallel-group comparison of drain removal timing.
- Masking
- None (open label)
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara Etlik City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Kemal Şibar, Ankara Etlik City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07302724
- Sponsor's protocol ID
- DrainCPM_TKA_2025
- Status last verified
- Dec 2025
- First submitted
- 10 Dec 2025
- Last updated
- 24 Dec 2025
- Results posted
- No
- Data monitoring committee
- 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 24 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Drain Removal Before Versus After Continuous Passive Motion in Primary Total Knee Arthroplasty: Impact on Residual Hematoma in a Prospective Controlled Study
- ClinicalTrials.gov ID
- NCT07302724
- Acronym / sponsor ID
- DrainCPM_TKA_2025
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Ankara Etlik City HospitalOther government
- Study start
- 15 Jun 2025 (actual)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 24 Dec 2025 (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 this prospective randomized controlled study was to determine whether the timing of drain removal in relation to continuous passive motion (CPM) application influences postoperative residual hematoma formation following primary total knee arthroplasty (TKA). Our primary hypothesis was that removing the drain after initiating CPM would result in less residual hematoma, as CPM-induced intra-articular fluid and blood mobilization would be evacuated through the drain before its removal, thereby reducing postoperative fluid accumulation.
Detailed description
This prospective, parallel-group interventional study was conducted at a single tertiary care center between June 2025 and December 2025 following approval by the institutional ethics committee. All patients provided written informed consent prior to participation.
A total of 104 consecutive patients undergoing primary unilateral total knee arthroplasty (TKA) were enrolled during the study period. During follow-up, four patients from each group were lost, leaving 96 patients available for final analysis.
Participants were allocated into two groups using a sequential alternating allocation method (2-1-2-1 sequence). Although not computer-generated, this prospective allocation approach ensured balanced group sizes throughout enrollment. Due to the nature of the intervention, allocation concealment and blinding were not applied.
All surgical procedures were performed by senior arthroplasty surgeons using a standardized medial parapatellar approach under spinal anesthesia. A uniform perioperative protocol was applied to all patients, including antibiotic prophylaxis with intravenous cefazolin and thromboembolism prophylaxis with low-molecular-weight heparin. All procedures were performed under tourniquet control. A single standard intra-articular hemovac drain of identical size and model was placed in all patients prior to wound closure.
Postoperatively, all patients underwent a standardized continuous passive motion (CPM) protocol approximately 24 hours after surgery. CPM was applied for 1 hour with a motion range of 0-90 degrees under supervision of the physiotherapy team.
The only interventional difference between study groups was the timing of drain removal in relation to CPM therapy. In the first group, the hemovac drain was removed immediately before initiation of CPM. In the second group, the drain was removed immediately after completion of the CPM session. All other perioperative care and rehabilitation protocols were identical between groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two-arm prospective parallel-group comparison of drain removal timing.
| Arm | Type | Receives |
|---|---|---|
| Drain Removal Before CPM | Other | Procedure: Drain Removal Before CPMThe hemovac drain is removed approximately 24 hours after surgery, immediately before a standardized 1-hour CPM session performed at 0-90° flexion. All other perioperative and rehabilitation protocols are identical between groups. |
| Drain Removal After CPM | Other | Procedure: Drain Removal After CPMPatients undergo a standardized 1-hour CPM session at 0-90° flexion approximately 24 hours after surgery. The hemovac drain is removed immediately after completion of the CPM session. All other perioperative and rehabilitation protocols are identical between groups. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18 years or older
- Undergoing primary unilateral total knee arthroplasty (TKA) for end-stage knee osteoarthritis
- Able to provide written informed consent
- Able to comply with scheduled postoperative follow-up assessments
Key exclusion criteria (5 listed)
- Revision total knee arthroplasty
- Previous infection in the index knee
- Inflammatory arthropathy
- Neuromuscular disorders affecting lower extremity function
- Inability to attend follow-up visits
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 |
|---|---|---|
| Drain Removal Before CPMHemovac drain removal performed approximately 24 hours after primary TKA, immediately before a standardized 1-hour CPM session (0-90°). All other surgical, perioperative, and rehabilitation protocols are identical across study arms. | Procedure or surgery | Drain Removal Before CPM |
| Drain Removal After CPMA standardized 1-hour CPM session at 0-90° is administered approximately 24 hours after primary TKA. The hemovac drain is removed immediately after completion of the CPM session. All other surgical, perioperative, and rehabilitation protocols are identical across study arms. | Procedure or surgery | Drain Removal After CPM |
Primary outcome
Residual Hematoma Formation
Time frame: Preoperative; Postoperative Day 2; Day 14; Day 28
Residual hematoma formation assessed by knee circumference measurements at the level of the superior pole of the patella. Circumference is measured on both the operated and contralateral knees. The difference from baseline and between-group differences are evaluated.
6 secondary outcomes
Wound Healing
Time frame: Postoperative Day 2; Day 14
Range of Motion (ROM)
Time frame: Preoperative; Postoperative Day 2; Day 14; Day 28
Pain Assessment
Time frame: Preoperative; Postoperative Day 14; Day 28
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Time frame: Preoperative; Postoperative Day 28
Lysholm Knee Score
Time frame: Preoperative; Postoperative Day 28
Oxford Knee Score
Time frame: Preoperative; Postoperative Day 28
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Drain Removal Before CPM and Drain Removal After CPM in people with Knee Osteoarthritis (Knee OA) and Total Knee Anthroplasty, run by Ankara Etlik City Hospital at 1 site in Turkey (Türkiye).
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 4 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 24 Dec 2025. 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 Turkey (Türkiye). 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?
This study is still under way. Results are not available in the source record yet.
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?
Residual Hematoma Formation (time frame: Preoperative; Postoperative Day 2; Day 14; Day 28). 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 24 Dec 2025.