Knee DiscomfortNCT05060536
Infrapatellar Fat Pad Excision in Total Knee Arthroplasty
A study testing Removal of infrapatellar fat pad and No removal of infrapatellar fat pad in people with Knee Discomfort and Arthroplasty Complications, run by NHS Greater Glasgow and Clyde at 1 site in United Kingdom.
Trial summary
To examine whether removing the infrapatellar fat pad from the knee during total knee arthroplasty affects the patient outcome in terms of pain and knee function following the procedure. Currently there is no consensus on whether removing this tissue from the knee has a positive or detrimental effect. Read more about this study
- Who is it for?
- Ages 40 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Knee Discomfort, Arthroplasty Complications
- What is being tested?
- Removal of infrapatellar fat pad and No removal of infrapatellar fat pad
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 256 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 31 Aug 2021to 31 Aug 2024
- Phase
- Interventional
- 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 40 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male/female patients between 40 and 100 years of age
- Undergoing primary total knee arthroplasty
Who cannot join
- Patient undergoing unicompartmental knee arthroplasty
- Patient undergoing revision knee arthroplasty
- Patient undergoing arthroplasty using non standard implants
- Previous patella surgery or injury
- Cognitive impairment
- Lack of conversational English
Trial locations and contacts
1 site in 1 country.
Nick Kane contact
United Kingdom1 site, 1 recruiting
- Recruiting
NHS Greater Glasgow and Clyde. Queen Elizabeth hospital (Victoria & Gartnavel)
Glasgow, Scotland, G51 4TF
Nicolas Kane, Nicholas.Kane@ggc.scot.nhs.uk
About this study
To examine whether removing the infrapatellar fat pad from the knee during total knee arthroplasty affects the patient outcome in terms of pain and knee function following the procedure. Currently there is no consensus on whether removing this tissue from the knee has a positive or detrimental effect. Small studies have been published, some showing improved symptoms and some worse symptoms. Current practice of orthopaedic surgeons is either to routinely remove or routinely retain the tissue when performing total knee arthroplasty.
Read the detailed description
Aim and Objectives The aim of the study is to examine whether removing or retaining the infrapatellar fat pad influences pain or knee function in the short and medium term.
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
- Knee Discomfort, Arthroplasty Complications
- Being tested
- Removal of infrapatellar fat pad, No removal of infrapatellar fat pad
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Removal of infrapatellar fat padProcedure or surgery
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 padProcedure or surgery
Retaining the infrapatellar fat pad during total knee replacement- no surgical removal.
| Study group | Role | What they receive |
|---|---|---|
| Removal of infrapatellar fat pad | Active comparator | When patients will have their fat pad removed. Receives: Procedure: Removal of infrapatellar fat pad |
| No removal of infrapatellar fat pad | Placebo comparator | When patients will not have their fat pad removed. Receives: Procedure: No removal of infrapatellar fat pad |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee pain
As assessed by patient reported outcome scores: Oxford knee score (0-48) Higher score better outcome.
Measured: 3 months post-operatively
Knee pain
As assessed by patient reported outcome scores: Oxford knee score (0-48) Higher score better outcome.
Measured: 1 year post-operatively
Knee pain
As assessed by patient reported outcome scores: Oxford knee score (0-48) Higher score better outcome.
Measured: 2 years post-operatively
Knee pain (Anterior)
As assessed by patient reported outcome scores: Kujala score (0-100) Higher score better outcome.
Measured: 3 months post-operatively
Knee pain (Anterior)
As assessed by patient reported outcome scores: Kujala score (0-100) Higher score better outcome.
Measured: 1 year post-operatively
Knee pain (Anterior)
As assessed by patient reported outcome scores: Kujala score (0-100) Higher score better outcome.
Measured: 2 years post-operatively
Knee function
As assessed by patient reported outcome scores: Oxford knee score (0-48) Higher score better outcome.
Measured: 3 months post-operatively
Knee function
As assessed by patient reported outcome scores: Oxford knee score (0-48) Higher score better outcome.
Measured: 1 year post-operatively
Knee function
As assessed by patient reported outcome scores: Oxford knee score (0-48) Higher score better outcome.
Measured: 2 years post-operatively
Secondary outcomes (6)
Knee Range of Movement- flexion and extension in degrees
Measured in degrees with goniometer
Measured: 3 months post-operatively
Knee Range of Movement- flexion and extension in degrees
Measured in degrees with goniometer
Measured: 1 year post-operatively
Knee Range of Movement- flexion and extension in degrees
Measured in degrees with goniometer
Measured: 2 years post-operatively
Shortening of patellar tendon- comparison between X-ray at 3 months with pre-operative X-ray
Measured on X-ray in millimeters
Measured: 3 months post-operatively
Shortening of patellar tendon- comparison between X-ray at 1 year with pre-operative X-ray
Measured on X-ray in millimeters
Measured: 1 year post-operatively
Shortening of patellar tendon- comparison between X-ray at 2 years with pre-operative X-ray
Measured on X-ray in millimeters
Measured: 2 years post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2021
- Study start31 Aug 2021
- Primary completion31 Aug 2024 (estimated)
- Study completion31 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee DiscomfortStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 256 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NHS Greater Glasgow and Clyde
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Simon Spencer, MBBS. FRCS., Study director, NHS Greater Glasgow and Clyde Board HQ
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05060536
- Sponsor's protocol ID
- 299830
- Status last verified
- Sep 2021
- First submitted
- 15 Sep 2021
- Last updated
- 13 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Infrapatellar Fat Pad Excision in Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT05060536
- Acronym / sponsor ID
- 299830
- Conditions
- Knee Discomfort, Arthroplasty Complications
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 256 participants (estimated)
- Lead sponsor
- NHS Greater Glasgow and ClydeUniversity, hospital or other
- Study start
- 31 Aug 2021 (actual)
- Primary completion
- 31 Aug 2024 (estimated)
- Study completion
- 31 Aug 2024 (estimated)
- First posted
- 29 Sep 2021 (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.
To examine whether removing the infrapatellar fat pad from the knee during total knee arthroplasty affects the patient outcome in terms of pain and knee function following the procedure. Currently there is no consensus on whether removing this tissue from the knee has a positive or detrimental effect. Small studies have been published, some showing improved symptoms and some worse symptoms. Current practice of orthopaedic surgeons is either to routinely remove or routinely retain the tissue when performing total knee arthroplasty.
Detailed description
Aim and Objectives The aim of the study is to examine whether removing or retaining the infrapatellar fat pad influences pain or knee function in the short and medium term.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Removal of infrapatellar fat pad | Active comparator | Procedure: Removal of infrapatellar fat padWhen patients will have their fat pad removed. |
| No removal of infrapatellar fat pad | Placebo comparator | Procedure: No removal of infrapatellar fat padWhen patients will not have their fat pad removed. |
Who may qualify
- Ages
- 40 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Male/female patients between 40 and 100 years of age
- Undergoing primary total knee arthroplasty
Key exclusion criteria (6 listed)
- Patient undergoing unicompartmental knee arthroplasty
- Patient undergoing revision knee arthroplasty
- Patient undergoing arthroplasty using non standard implants
- Previous patella surgery or injury
- Cognitive impairment
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 |
|---|---|---|
| Removal of infrapatellar fat padThere 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. | Procedure or surgery | Removal of infrapatellar fat pad |
| No removal of infrapatellar fat padRetaining the infrapatellar fat pad during total knee replacement- no surgical removal. | Procedure or surgery | No removal of infrapatellar fat pad |
Primary outcome
Knee pain
Time frame: 3 months post-operatively
As assessed by patient reported outcome scores: Oxford knee score (0-48) Higher score better outcome.
Knee pain
Time frame: 1 year post-operatively
As assessed by patient reported outcome scores: Oxford knee score (0-48) Higher score better outcome.
Knee pain
Time frame: 2 years post-operatively
As assessed by patient reported outcome scores: Oxford knee score (0-48) Higher score better outcome.
Knee pain (Anterior)
Time frame: 3 months post-operatively
As assessed by patient reported outcome scores: Kujala score (0-100) Higher score better outcome.
Knee pain (Anterior)
Time frame: 1 year post-operatively
As assessed by patient reported outcome scores: Kujala score (0-100) Higher score better outcome.
Knee pain (Anterior)
Time frame: 2 years post-operatively
As assessed by patient reported outcome scores: Kujala score (0-100) Higher score better outcome.
Knee function
Time frame: 3 months post-operatively
As assessed by patient reported outcome scores: Oxford knee score (0-48) Higher score better outcome.
Knee function
Time frame: 1 year post-operatively
As assessed by patient reported outcome scores: Oxford knee score (0-48) Higher score better outcome.
Knee function
Time frame: 2 years post-operatively
As assessed by patient reported outcome scores: Oxford knee score (0-48) Higher score better outcome.
6 secondary outcomes
Knee Range of Movement- flexion and extension in degrees
Time frame: 3 months post-operatively
Knee Range of Movement- flexion and extension in degrees
Time frame: 1 year post-operatively
Knee Range of Movement- flexion and extension in degrees
Time frame: 2 years post-operatively
Shortening of patellar tendon- comparison between X-ray at 3 months with pre-operative X-ray
Time frame: 3 months post-operatively
Shortening of patellar tendon- comparison between X-ray at 1 year with pre-operative X-ray
Time frame: 1 year post-operatively
Shortening of patellar tendon- comparison between X-ray at 2 years with pre-operative X-ray
Time frame: 2 years post-operatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2021.
- Individual participant dataSharing planned: No
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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.
Nick Kane contact
Simon Spencer, MBBS. FRCS. study director
NHS Greater Glasgow and Clyde Board HQ
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Removal of infrapatellar fat pad and No removal of infrapatellar fat pad in people with Knee Discomfort and Arthroplasty Complications, run by NHS Greater Glasgow and Clyde at 1 site in United Kingdom.
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 6 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: status not confirmed, as of the sponsor's last update on 13 Oct 2021. 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 United Kingdom. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mairiosa Biddle, MBBS. MRCS. (07743410129, Mairiosa.Biddle@ggc.scot.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knee pain (time frame: 3 months post-operatively). The study lists 9 primary outcomes in all. 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 13 Oct 2021.