NCT05638386

Effect of Plugging the Registration Pin Tract in Robotic-assisted Knee Surgery

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 384 (actual)
• Sponsor: Reinier Haga Orthopedisch Centrum · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: —

Summary

Introduction: Complications of robotic-assisted total knee arthroplasty (TKA) seem to be rare and consist mainly of infections or fractures. In the Reinier Haga Orthopedisch Centrum (RHOC), postoperative bleeding is experienced to be a complication that often occurs, mainly at the tibial wounds of the registration pins used in robotic-assisted TKA. This often results in longer hospital stay and might interfere with the current fast track knee surgery by a delayed discharge. To overcome this complication, nowadays bone plugs are used in the two drill-holes. Currently, it is unknown whether these bone plugs reduces the incidence of postoperative bleeding. Objective: To evaluate the incidence of postoperative bleeding in patients that underwent a robotic-assisted TKA and received bone plugs in the two drill-holes in the tibia, compared to patients that underwent the same operation but did not receive bone plugs. Study design: Retrospective, inventory study Study population: All patients that underwent a robotic-assisted TKA in the RHOC from December 2020 till October 2022. Intervention: In the past, some patients that underwent a robotic-assisted TKA received a bone plug in the two tibial drill-holes. This bone is collected from the excess bone that is removed during the operation. Main study parameters/endpoints: Incidence of postoperative bleeding in both groups.

Conditions

• Arthropathy of Knee
• Complication of Surgical Procedure

Interventions

Type	Name	Description
PROCEDURE	Bone plug	The investigational treatment is the use of a bone plug in the two drill-holes in the tibia, made by two pins for securing the tibial array to the bone. The pins that are used for this, are 4.0mm wide. The bone plug that is used to fill the drill-holes of tibia, is obtained from the bone that is removed during the operation to make place for the new prosthesis. A piece as wide as the drill-hole is cut off the recessed bone and put into this hole. After this, the wound is closed using surgical staples.

Timeline

• Start date: 2022-12-01
• Primary completion: 2023-01-31
• Completion: 2023-03-20
• First posted: 2022-12-06
• Last updated: 2023-03-21

Locations

1 site across 1 country: Netherlands