Patients With Higher BMI Produces More Postoperative Drainage Volume and Length of Stay in Cross-Sectional Study

• Sponsor: Indonesia University (Other)
• Overall Status: Completed
• CT.gov ID: NCT05998538
• Collaborator: (none)
• Enrollment: 120
• Location: 1
• Actual Duration (Months): 35.5
• Patients Per Site Per Month: 3.4

Study Details

Study Description

Brief 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. This study compared the postoperative drainage volume and length of stay (LOS) of TKA vs UKA and evaluated its comparison with patient characteristics.

Condition or Disease	Intervention/Treatment	Phase
Osteoarthritis, Knee	Procedure: Knee Replacement

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

• Study Type: Observational
• Actual Enrollment: 120 participants
• Observational Model: Case-Crossover
• Time Perspective: Retrospective
• 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
• Actual Study Start Date: Dec 23, 2019
• Actual Primary Completion Date: Oct 21, 2022
• Actual Study Completion Date: Dec 7, 2022

Arms and Interventions

Arm	Intervention/Treatment
TKA (Total Knee Arthroplasty) procedure Total Knee Arthroplasty	Procedure: Knee Replacement; Total vs Partial Knee Replacement
UKA (Uni Knee Arthroplasty) procedure Uni Knee Arthroplasty	Procedure: Knee Replacement; Total vs Partial Knee Replacement

Outcome Measures

Primary Outcome Measures

1. Drainage Volume [3-5 days post op]

   total drainage volume

Secondary Outcome Measures

1. LOS [pre-op until drainage removed, 3-6 days post op]

   length of stay

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• grade 4 Osteoarthritis

Exclusion Criteria:

• previous trauma

• infection

• blood coagulation disorder

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pondok Indah Hospital	Jakarta		Indonesia

Sponsors and Collaborators

• Indonesia University

Investigators

• Study Director: Ismail H Dilogo, Prof, Indonesia University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ludwig Andre Pontoh, DR, Indonesia University
• ClinicalTrials.gov Identifier: NCT05998538
• Other Study ID Numbers: 23082020
• First Posted: Aug 21, 2023
• Last Update Posted: Aug 21, 2023
• Last Verified: Aug 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Osteoarthritis, Knee

Study Results

No Results Posted as of Aug 21, 2023