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

Complication of Surgical Procedure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05638386
• Other study ID #: OC-2022-002
• Status: Completed
• Start date: December 1, 2022
• Est. completion date: March 20, 2023

Study information

• Verified date: November 2022
• Source: Reinier Haga Orthopedisch Centrum
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 384
• Est. completion date: March 20, 2023
• Est. primary completion date: January 31, 2023
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Arthropathy of Knee
• Complication of Surgical Procedure
• Joint Diseases

Intervention

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.

Locations

Country	Name	City	State
Netherlands	RHOC	Zoetermeer	Zuid- Holland

Sponsors (1)

Lead Sponsor	Collaborator
Reinier Haga Orthopedisch Centrum

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with postoperative bleeding		December 2020 - October 2022
Secondary	Length of hospital stay		December 2020 - October 2022
Secondary	Complications		December 2020 - October 2022
Secondary	Reasons which might lengthen hospital stay		December 2020 - October 2022