Drain Removal Before Versus After CPM in Primary Total Knee Arthroplasty

NCT07302724 | Active Not Recruiting

• 1 other identifier: DrainCPM_TKA_2025
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

Knee Osteoarthritis (Knee OA); Total Knee Anthroplasty; Postoperative Hematoma

Outcome Measures

Primary Outcomes (1)

• 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.

  Preoperative; Postoperative Day 2; Day 14; Day 28

Secondary Outcomes (6)

• Wound Healing

  Postoperative Day 2; Day 14

• Range of Motion (ROM)

  Preoperative; Postoperative Day 2; Day 14; Day 28

• Pain Assessment

  Preoperative; Postoperative Day 14; Day 28

• Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

  Preoperative; Postoperative Day 28

• Lysholm Knee Score

  Preoperative; Postoperative Day 28

Study Arms (2)

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.

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.

Procedure: Drain Removal After CPM

Interventions

Drain Removal Before CPM PROCEDURE

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 Before CPM

Drain Removal After CPM PROCEDURE

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.

Drain Removal After CPM

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Revision total knee arthroplasty
• Previous infection in the index knee
• Inflammatory arthropathy
• Neuromuscular disorders affecting lower extremity function
• Inability to attend follow-up visits

Sponsors & Collaborators

• Ankara Etlik City Hospital: lead

Study Sites (1)

Ankara Etlik City Hospital

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Orthopedic Surgeon, Principal Investigator

Model Details: Two-arm prospective parallel-group comparison of drain removal timing.

Study Record Dates

• First Submitted: December 10, 2025
• First Posted: December 24, 2025
• Study Start: June 15, 2025
• Primary Completion: December 30, 2025
• Study Completion: December 30, 2025
• Last Updated: December 24, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)