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

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.

Study Overview

• Status: Completed
• Conditions: Complication of Surgical Procedure; Arthropathy of Knee
• Intervention / Treatment: Procedure: Bone plug

• Study Type: Observational
• Enrollment (Actual): 384

Contacts and Locations

Study Locations

• Netherlands
  • Zuid- Holland
    • Zoetermeer, Zuid- Holland, Netherlands, 2725 NA
      • RHOC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All patients who underwent robotic-assisted total knee arthroplasty in the RHOC between December 2020 and October 2022

Description

Inclusion Criteria:

• Underwent robotic-assisted total knee arthroplasty between December 2020 and October 2022 with or without the use of bone plugs
• Does not object against use of medical data

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients who underwent a robotic-assisted total knee arthroplasty with the use of bone plugs	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.
Patients who underwent a robotic-assisted total knee arthroplasty without the use of bone plugs

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of patients with postoperative bleeding	December 2020 - October 2022

Secondary Outcome Measures

Outcome Measure	Time Frame
Length of hospital stay	December 2020 - October 2022
Complications	December 2020 - October 2022
Reasons which might lengthen hospital stay	December 2020 - October 2022

Collaborators and Investigators

• Sponsor: Reinier Haga Orthopedisch Centrum

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2022
• Primary Completion (Actual): January 31, 2023
• Study Completion (Actual): March 20, 2023

Study Registration Dates

• First Submitted: November 25, 2022
• First Submitted That Met QC Criteria: November 25, 2022
• First Posted (Actual): December 6, 2022

Study Record Updates

• Last Update Posted (Actual): March 21, 2023
• Last Update Submitted That Met QC Criteria: March 20, 2023
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Robotic-assisted surgery; Bone plug
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Joint Diseases
• Other Study ID Numbers: OC-2022-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No