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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05638386
Enrollment
384
Registered
2022-12-06
Start date
2022-12-01
Completion date
2023-03-20
Last updated
2023-03-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arthropathy of Knee, Complication of Surgical Procedure

Keywords

Robotic-assisted surgery, Bone plug

Brief 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.

Interventions

PROCEDUREBone 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.

Sponsors

Reinier Haga Orthopedisch Centrum
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL

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

Design outcomes

Primary

MeasureTime frame
Number of patients with postoperative bleedingDecember 2020 - October 2022

Secondary

MeasureTime frame
Length of hospital stayDecember 2020 - October 2022
ComplicationsDecember 2020 - October 2022
Reasons which might lengthen hospital stayDecember 2020 - October 2022

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026