Arthropathy of KneeNCT05638386
Effect of Plugging the Registration Pin Tract in Robotic-assisted Knee Surgery
An observational study of Arthropathy of Knee and Complication of Surgical Procedure, run by Reinier Haga Orthopedisch Centrum at 1 site in Netherlands.
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Arthropathy of Knee, Complication of Surgical Procedure
- What is being tested?
- Bone plug
- Type of treatment
- Surgery or procedure
- How many people
- 384 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Dec 2022to 20 Mar 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older adult
Study population: All patients who underwent robotic-assisted total knee arthroplasty in the RHOC between December 2020 and October 2022
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
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.
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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.
- Being tested
- Bone plug
- Keywords
- Robotic-assisted surgery, Bone plug
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bone plugProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients who underwent a robotic-assisted total knee arthroplasty with the use of bone plugs | Not described Receives: Procedure: Bone plug | |
| Patients who underwent a robotic-assisted total knee arthroplasty without the use of bone plugs | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with postoperative bleeding
Measured: December 2020 - October 2022
Secondary outcomes (3)
Length of hospital stay
Measured: December 2020 - October 2022
Complications
Measured: December 2020 - October 2022
Reasons which might lengthen hospital stay
Measured: December 2020 - October 2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2022
- Study start1 Dec 2022
- Primary completion31 Jan 2023
- Study completion20 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthropathy of KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 384 participants (actual)
Sponsor and investigators
- Lead sponsor
- Reinier Haga Orthopedisch Centrum
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05638386
- Sponsor's protocol ID
- OC-2022-002
- Status last verified
- Nov 2022
- First submitted
- 25 Nov 2022
- Last updated
- 21 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Plugging the Registration Pin Tract in Robotic-assisted Knee Surgery
- ClinicalTrials.gov ID
- NCT05638386
- Acronym / sponsor ID
- OC-2022-002
- Keywords
- Robotic-assisted surgery, Bone plug
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 384 participants (actual)
- Lead sponsor
- Reinier Haga Orthopedisch CentrumUniversity, hospital or other
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 31 Jan 2023 (actual)
- Study completion
- 20 Mar 2023 (actual)
- First posted
- 6 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients who underwent a robotic-assisted total knee arthroplasty with the use of bone plugs | – | Procedure: Bone plug |
| Patients who underwent a robotic-assisted total knee arthroplasty without the use of bone plugs | – | – |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- All patients who underwent robotic-assisted total knee arthroplasty in the RHOC between December 2020 and October 2022
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bone plugThe 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. | Procedure or surgery | Patients who underwent a robotic-assisted total knee arthroplasty with the use of bone plugs |
Primary outcome
Number of patients with postoperative bleeding
Time frame: December 2020 - October 2022
3 secondary outcomes
Length of hospital stay
Time frame: December 2020 - October 2022
Complications
Time frame: December 2020 - October 2022
Reasons which might lengthen hospital stay
Time frame: December 2020 - October 2022
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arthropathy of Knee and Complication of Surgical Procedure, run by Reinier Haga Orthopedisch Centrum at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with postoperative bleeding (time frame: December 2020 - October 2022). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2023.