Infrapatellar Fat Pad Excision in Total Knee Arthroplasty
1 other identifier
interventional
256
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2021
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 31, 2021
CompletedFirst Submitted
Initial submission to the registry
September 15, 2021
CompletedFirst Posted
Study publicly available on registry
September 29, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2024
CompletedOctober 13, 2021
September 1, 2021
3 years
September 15, 2021
October 5, 2021
Conditions
Outcome Measures
Primary Outcomes (9)
Knee pain
As assessed by patient reported outcome scores: Oxford knee score (0-48) Higher score better outcome.
3 months post-operatively
Knee pain
As assessed by patient reported outcome scores: Oxford knee score (0-48) Higher score better outcome.
1 year post-operatively
Knee pain
As assessed by patient reported outcome scores: Oxford knee score (0-48) Higher score better outcome.
2 years post-operatively
Knee pain (Anterior)
As assessed by patient reported outcome scores: Kujala score (0-100) Higher score better outcome.
3 months post-operatively
Knee pain (Anterior)
As assessed by patient reported outcome scores: Kujala score (0-100) Higher score better outcome.
1 year post-operatively
Knee pain (Anterior)
As assessed by patient reported outcome scores: Kujala score (0-100) Higher score better outcome.
2 years post-operatively
Knee function
As assessed by patient reported outcome scores: Oxford knee score (0-48) Higher score better outcome.
3 months post-operatively
Knee function
As assessed by patient reported outcome scores: Oxford knee score (0-48) Higher score better outcome.
1 year post-operatively
Knee function
As assessed by patient reported outcome scores: Oxford knee score (0-48) Higher score better outcome.
2 years post-operatively
Secondary Outcomes (6)
Knee Range of Movement- flexion and extension in degrees
3 months post-operatively
Knee Range of Movement- flexion and extension in degrees
1 year post-operatively
Knee Range of Movement- flexion and extension in degrees
2 years post-operatively
Shortening of patellar tendon- comparison between X-ray at 3 months with pre-operative X-ray
3 months post-operatively
Shortening of patellar tendon- comparison between X-ray at 1 year with pre-operative X-ray
1 year post-operatively
- +1 more secondary outcomes
Study Arms (2)
Removal of infrapatellar fat pad
ACTIVE COMPARATORWhen patients will have their fat pad removed.
No removal of infrapatellar fat pad
PLACEBO COMPARATORWhen patients will not have their fat pad removed.
Interventions
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.
Retaining the infrapatellar fat pad during total knee replacement- no surgical removal.
Eligibility Criteria
You may qualify if:
- Male/female patients between 40 and 100 years of age
- Undergoing primary total knee arthroplasty
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
NHS Greater Glasgow and Clyde. Queen Elizabeth hospital (Victoria & Gartnavel)
Glasgow, Scotland, G51 4TF, United Kingdom
Study Officials
- STUDY DIRECTOR
Simon Spencer, MBBS. FRCS.
NHS Greater Glasgow and Clyde Board HQ
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- double blinded RCT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 15, 2021
First Posted
September 29, 2021
Study Start
August 31, 2021
Primary Completion
August 31, 2024
Study Completion
August 31, 2024
Last Updated
October 13, 2021
Record last verified: 2021-09
Data Sharing
- IPD Sharing
- Will not share