Clinical Trials Logo

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.


Clinical Trial 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


Related Conditions & MeSH terms


NCT number NCT05060536
Study type Interventional
Source NHS Greater Glasgow and Clyde
Contact Mairiosa Biddle, MBBS. MRCS.
Phone 07743410129
Email [email protected]
Status Recruiting
Phase N/A
Start date August 31, 2021
Completion date August 31, 2024

See also
  Status Clinical Trial Phase
Suspended NCT04289025 - Modelling and AI Using Sensor Data to Personalise REHABilitation Following Joint Replacement N/A
Completed NCT04490304 - The Analysis of Posterior Soft Tissue Repair Durability N/A
Completed NCT04565093 - Efficacy of iPACK After Unilateral TKA N/A
Recruiting NCT03306810 - Recognition and Treatment of Dysglycemia. AGS - Acute Glucose Service N/A
Not yet recruiting NCT05014932 - Evaluation of Noise Induced by Ceramic-ceramic Friction Torques of Total Hip Prostheses With Customized Femoral Stem
Recruiting NCT04437888 - Intraoperative Ketamine for Patients Undergoing Total Joint Arthroplasty Early Phase 1
Completed NCT03269760 - Multimodal Sleep Pathway for Shoulder Arthroplasty Phase 1
Completed NCT03289247 - Tissue Adhaesive in Wound Closure Following Primary Total Knee Arthroplasty N/A
Completed NCT04433962 - Investigation of the Effects of Balance Training on Balance and Functional Status Patients With Total Hip Arthroplasty N/A
Active, not recruiting NCT03692364 - Evaluation of Metal-on-conventional-polyethylene vs Ceramic-on-ceramic Articulating Surfaces in Total Hip Arthroplasty N/A
Completed NCT04120324 - Incidence of 30 Day Return to Hospital Following Same Day Discharge Total Hip Arthroplasty
Not yet recruiting NCT04539730 - Liposomal Bupivacaine in Adductor Canal Blocks (ACB) Phase 4
Completed NCT03984942 - Bypass PACU in Knee and Hip Arthroplasty
Not yet recruiting NCT05013879 - Kinesiotape for Edema After Bilateral Total Knee Arthroplasty N/A
Completed NCT03894514 - Multi-variable Prediction Model of Total Knee Replacement Outcome
Completed NCT04107350 - The Whole Body Vibration Training for Total Knee arthroplasty-the Improvement of the Lower Limb N/A
Recruiting NCT04913623 - Correlation of Intramedullary Pressure and Systemic Inflammatory Parameters in Cemented Femoral Stem
Not yet recruiting NCT04227873 - Sleep and Cognition After Ambulatory Hip and Knee Arthroplasty
Completed NCT03930537 - Change of Intramedullar Pressure After Implantation of Hip Prothesis N/A
Recruiting NCT05060952 - Calprotectin in Chronic Prosthetic Joint Infection