Infrapatellar Fat Pad Excision in Total Knee Arthroplasty
NCT ID: NCT05060536
Last Updated: 2021-10-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
256 participants
INTERVENTIONAL
2021-08-31
2024-08-31
Brief Summary
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Detailed Description
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Study Design A single centre randomized controlled trial of total knee arthroplasty with and without infrapatellar fat pad excision
Methodology A research nurse or the responsible consultant orthopaedic surgeon will identify potentially eligible patients from the list of those invited to attend the pre-operative assessment clinic for total knee arthroplasty. As part of their written invitation to attend this clinic, they will receive an information leaflet about the study from their consultant.
A research nurse or the responsible consultant orthopaedic surgeon will discuss the trial with them at the pre-assessment clinic. If the patient is willing to take part in the study they would then be asked to sign a consent form and will be reminded of the opportunity to withdraw from the study at any point. Their consent will be confirmed on the day of their admission for surgery.
Consented patients will be randomized to one of two arms of the study, the only variable being whether or not the infrapatellar fat pad is excised.
Randomisation to excision or retention of the infrapatellar fat pad will occur immediately prior to the total knee arthroplasty procedure being performed, and will be performed using the program freely available at http://www.randomization.com. Sealed envelopes will be prepared and the operating surgeon will open the randomisation envelope immediately before performing the total knee arthroplasty procedure. The procedure will then be performed and recorded. The excision of the infrapatellar fat pad itself takes less than 20 seconds to perform, and the knee replacement procedure is otherwise performed as normal. The outcome of the randomisation and procedure performed will be known only to the operating surgeon and researcher and not to those following up the patients and recording the outcome measures.
Seven consultant orthopaedic surgeons will take part in the trial. All perform total knee arthroplasty surgery regularly . Other than the consent process and additional questionnaires and clinical assessment performed, the care of patients in the study will be identical to all other non-study patients. Follow up will follow our normal routine pathway of visits at 3 months, 1 year and 2 years.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Removal of infrapatellar fat pad
When patients will have their fat pad removed.
Removal of infrapatellar fat pad
There is no agreed protocol for retaining or excising the infrapatellar fat pad with many surgeons routinely completely removing the fat pad to improve view of the proximal tibia while others opt to retain or minimally excise the tissue.
We are aware of no risks involved in performing this procedure and current practice of many orthopaedic surgeons is either to routinely remove or routinely retain the infrapatellar fat pad when performing total knee arthroplasty.
The potential benefits are that we will understand better whether removing or retaining this tissue does have a role in influencing outcomes after total knee replacement surgery. The results will be disseminated to the wider orthopaedic community to inform practice with the aim or improving outcomes from total knee arthroplasty.
No removal of infrapatellar fat pad
When patients will not have their fat pad removed.
No removal of infrapatellar fat pad
Retaining the infrapatellar fat pad during total knee replacement- no surgical removal.
Interventions
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Removal of infrapatellar fat pad
There is no agreed protocol for retaining or excising the infrapatellar fat pad with many surgeons routinely completely removing the fat pad to improve view of the proximal tibia while others opt to retain or minimally excise the tissue.
We are aware of no risks involved in performing this procedure and current practice of many orthopaedic surgeons is either to routinely remove or routinely retain the infrapatellar fat pad when performing total knee arthroplasty.
The potential benefits are that we will understand better whether removing or retaining this tissue does have a role in influencing outcomes after total knee replacement surgery. The results will be disseminated to the wider orthopaedic community to inform practice with the aim or improving outcomes from total knee arthroplasty.
No removal of infrapatellar fat pad
Retaining the infrapatellar fat pad during total knee replacement- no surgical removal.
Eligibility Criteria
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Inclusion Criteria
* Undergoing primary total knee arthroplasty
Exclusion Criteria
* Patient undergoing revision knee arthroplasty
* Patient undergoing arthroplasty using non standard implants
* Previous patella surgery or injury
* Cognitive impairment
* Lack of conversational English
40 Years
100 Years
ALL
Yes
Sponsors
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NHS Greater Glasgow and Clyde
OTHER
Responsible Party
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Principal Investigators
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Simon Spencer, MBBS. FRCS.
Role: STUDY_DIRECTOR
NHS Greater Glasgow and Clyde Board HQ
Locations
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NHS Greater Glasgow and Clyde. Queen Elizabeth hospital (Victoria & Gartnavel)
Glasgow, Scotland, United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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299830
Identifier Type: -
Identifier Source: org_study_id