Drain Removal Before Versus After CPM in Primary Total Knee Arthroplasty
NCT ID: NCT07302724
Last Updated: 2025-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ACTIVE_NOT_RECRUITING
NA
104 participants
INTERVENTIONAL
2025-06-15
2025-12-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Drain Removal Before CPM
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.
Drain Removal Before CPM
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 CPM
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.
Drain Removal After CPM
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Drain Removal Before CPM
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 CPM
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
Exclusion Criteria
* Previous infection in the index knee
* Inflammatory arthropathy
* Neuromuscular disorders affecting lower extremity function
* Inability to attend follow-up visits
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Ankara Etlik City Hospital
OTHER_GOV
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Kemal Şibar
Orthopedic Surgeon, Principal Investigator
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Ankara Etlik City Hospital
Ankara, , Turkey (Türkiye)
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
DrainCPM_TKA_2025
Identifier Type: -
Identifier Source: org_study_id