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Completed

NCT Number: NCT05638386

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.

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Key information

Conditions

Arthropathy of Knee Complication of Surgical Procedure

Sex eligibility

All sexes

Study type

Observational

Primary location

RHOC

Zoetermeer, South Holland, 2725 NA, Netherlands

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bone plug

Procedure

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.

Primary outcomes

  1. Number of patients with postoperative bleeding

    Time frame: December 2020 - October 2022

Secondary outcomes

  1. Length of hospital stay

    Time frame: December 2020 - October 2022

  2. Complications

    Time frame: December 2020 - October 2022

  3. Reasons which might lengthen hospital stay

    Time frame: December 2020 - October 2022

Sponsors and collaborators

Lead sponsor

Reinier Haga Orthopedisch Centrum

Other

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Dec 6, 2022
Registry last updated
Mar 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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