- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05060536
Infrapatellar Fat Pad Excision in Total Knee Arthroplasty
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Mairiosa Biddle, MBBS. MRCS.
- Phone Number: 07743410129
- Email: Mairiosa.Biddle@ggc.scot.nhs.uk
Study Contact Backup
- Name: Nick Kane
- Email: Nicholas.Kane@ggc.scot.nhs.uk
Study Locations
-
-
Scotland
-
Glasgow, Scotland, United Kingdom, G51 4TF
- Recruiting
- NHS Greater Glasgow and Clyde. Queen Elizabeth hospital (Victoria & Gartnavel)
-
Contact:
- Nicolas Kane
- Email: Nicholas.Kane@ggc.scot.nhs.uk
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Removal of infrapatellar fat pad
When patients will have their fat pad removed.
|
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. |
Placebo Comparator: No removal of infrapatellar fat pad
When patients will not have their fat pad removed.
|
Retaining the infrapatellar fat pad during total knee replacement- no surgical removal.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Knee pain
Time Frame: 3 months post-operatively
|
As assessed by patient reported outcome scores: Oxford knee score (0-48) Higher score better outcome.
|
3 months post-operatively
|
Knee pain
Time Frame: 1 year post-operatively
|
As assessed by patient reported outcome scores: Oxford knee score (0-48) Higher score better outcome.
|
1 year post-operatively
|
Knee pain
Time Frame: 2 years post-operatively
|
As assessed by patient reported outcome scores: Oxford knee score (0-48) Higher score better outcome.
|
2 years post-operatively
|
Knee pain (Anterior)
Time Frame: 3 months post-operatively
|
As assessed by patient reported outcome scores: Kujala score (0-100) Higher score better outcome.
|
3 months post-operatively
|
Knee pain (Anterior)
Time Frame: 1 year post-operatively
|
As assessed by patient reported outcome scores: Kujala score (0-100) Higher score better outcome.
|
1 year post-operatively
|
Knee pain (Anterior)
Time Frame: 2 years post-operatively
|
As assessed by patient reported outcome scores: Kujala score (0-100) Higher score better outcome.
|
2 years post-operatively
|
Knee function
Time Frame: 3 months post-operatively
|
As assessed by patient reported outcome scores: Oxford knee score (0-48) Higher score better outcome.
|
3 months post-operatively
|
Knee function
Time Frame: 1 year post-operatively
|
As assessed by patient reported outcome scores: Oxford knee score (0-48) Higher score better outcome.
|
1 year post-operatively
|
Knee function
Time Frame: 2 years post-operatively
|
As assessed by patient reported outcome scores: Oxford knee score (0-48) Higher score better outcome.
|
2 years post-operatively
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Knee Range of Movement- flexion and extension in degrees
Time Frame: 3 months post-operatively
|
Measured in degrees with goniometer
|
3 months post-operatively
|
Knee Range of Movement- flexion and extension in degrees
Time Frame: 1 year post-operatively
|
Measured in degrees with goniometer
|
1 year post-operatively
|
Knee Range of Movement- flexion and extension in degrees
Time Frame: 2 years post-operatively
|
Measured in degrees with goniometer
|
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
|
Measured on X-ray in millimeters
|
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
|
Measured on X-ray in millimeters
|
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
|
Measured on X-ray in millimeters
|
2 years post-operatively
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Simon Spencer, MBBS. FRCS., NHS Greater Glasgow and Clyde Board HQ
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 299830
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Arthroplasty Complications
-
Hospital for Special Surgery, New YorkMedical College of WisconsinRecruitingComplications; Arthroplasty | Complications; Arthroplasty, MechanicalUnited States
-
Centre Hospitalier Universitaire de NiceRecruitingArthroplasty ComplicationsFrance
-
Afyonkarahisar Health Sciences UniversityRecruiting
-
Restor3DCompletedComplications; ArthroplastyUnited States
-
Groupe Hospitalier de la Rochelle Ré AunisCompletedArthroplasty ComplicationsFrance
-
Stryker OrthopaedicsCompleted
-
GCS Ramsay Santé pour l'Enseignement et la RechercheNot yet recruitingArthroplasty ComplicationsFrance
-
Central Hospital, Nancy, FranceCompleted
-
Centre Hospitalier Universitaire, AmiensCompletedArthroplasty Complications
-
Norfolk and Norwich University Hospitals NHS Foundation...University of East Anglia; Dynamic Metrics LtdCompletedArthroplasty ComplicationsUnited Kingdom
Clinical Trials on Removal of infrapatellar fat pad
-
Zhujiang HospitalThe First Affiliated Hospital of Anhui Medical University; Xiangya Hospital... and other collaboratorsRecruitingKnee Osteoarthritis | Arthropathy of KneeChina
-
Aksaray University Training and Research HospitalCompletedOsteoarthritis, Knee | Knee ArthritisTurkey
-
Liverpool University Hospitals NHS Foundation TrustCompleted
-
EMO Biomedicine CorporationFar Eastern Memorial HospitalCompleted
-
University of PittsburghCompleted
-
University Hospital, GhentRecruiting
-
Tanta UniversityRecruitingOro-Antral CommunicationEgypt
-
University of Sao Paulo General HospitalNot yet recruitingKnee Injuries | Cartilage Injury | Cell- and Tissue-Based Therapy
-
Cairo UniversityNot yet recruiting
-
Universidade PositivoCompletedGingival Recession