Infrapatellar Fat Pad Excision in Total Knee Arthroplasty

Arthroplasty Complications Clinical Trial

Official title:

Infrapatellar Fat Pad Excision in Total Knee Arthroplasty

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05060536
• Other study ID #: 299830
• Status: Recruiting
• Phase: N/A
• Start date: August 31, 2021
• Est. completion date: August 31, 2024

Study information

• Verified date: September 2021
• Source: NHS Greater Glasgow and Clyde
• Contact: Mairiosa Biddle, MBBS. MRCS.
• Phone: 07743410129
• Email: Mairiosa.Biddle[@]ggc.scot.nhs.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 256
• Est. completion date: August 31, 2024
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 100 Years

Eligibility

Inclusion Criteria:

• Male/female patients between 40 and 100 years of age

• Undergoing primary total knee arthroplasty

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Arthroplasty Complications
• Knee Discomfort

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
United Kingdom	NHS Greater Glasgow and Clyde. Queen Elizabeth hospital (Victoria & Gartnavel)	Glasgow	Scotland

Sponsors (1)

Lead Sponsor	Collaborator
NHS Greater Glasgow and Clyde

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Knee pain	As assessed by patient reported outcome scores: Oxford knee score (0-48) Higher score better outcome.	3 months post-operatively
Primary	Knee pain	As assessed by patient reported outcome scores: Oxford knee score (0-48) Higher score better outcome.	1 year post-operatively
Primary	Knee pain	As assessed by patient reported outcome scores: Oxford knee score (0-48) Higher score better outcome.	2 years post-operatively
Primary	Knee pain (Anterior)	As assessed by patient reported outcome scores: Kujala score (0-100) Higher score better outcome.	3 months post-operatively
Primary	Knee pain (Anterior)	As assessed by patient reported outcome scores: Kujala score (0-100) Higher score better outcome.	1 year post-operatively
Primary	Knee pain (Anterior)	As assessed by patient reported outcome scores: Kujala score (0-100) Higher score better outcome.	2 years post-operatively
Primary	Knee function	As assessed by patient reported outcome scores: Oxford knee score (0-48) Higher score better outcome.	3 months post-operatively
Primary	Knee function	As assessed by patient reported outcome scores: Oxford knee score (0-48) Higher score better outcome.	1 year post-operatively
Primary	Knee function	As assessed by patient reported outcome scores: Oxford knee score (0-48) Higher score better outcome.	2 years post-operatively
Secondary	Knee Range of Movement- flexion and extension in degrees	Measured in degrees with goniometer	3 months post-operatively
Secondary	Knee Range of Movement- flexion and extension in degrees	Measured in degrees with goniometer	1 year post-operatively
Secondary	Knee Range of Movement- flexion and extension in degrees	Measured in degrees with goniometer	2 years post-operatively
Secondary	Shortening of patellar tendon- comparison between X-ray at 3 months with pre-operative X-ray	Measured on X-ray in millimeters	3 months post-operatively
Secondary	Shortening of patellar tendon- comparison between X-ray at 1 year with pre-operative X-ray	Measured on X-ray in millimeters	1 year post-operatively
Secondary	Shortening of patellar tendon- comparison between X-ray at 2 years with pre-operative X-ray	Measured on X-ray in millimeters	2 years post-operatively