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Completed

NCT Number: NCT04503512

Surgical Excision of the Fat Pad

Introduction:

The infrapatellar fat pad (Hoffa's fat pad) is a structure which is located intra-articularly. Its function is not well known. During knee replacement surgery, some surgeons would prefer removing the whole of the fat pad as this can improve exposure of the knee joint, as it can affect exposure of the knee joint which will in turn make the procedure slightly more efficient. Other surgeons would rather resect the minimum amount and preserve the bulk of the structure as anecdotally this is thought to decrease the level of post operative pain. This surgical step fat pad resection is a very small part of the whole total knee replacement procedure.

A previous retrospective review of patients whose fat pad had been removed showed that they were nearly twice as likely to experience postoperative pain (P = 0.0005), while another study showed that they are at a slight risk of patellar tendon shortening.

A randomised controlled trial of 68 patients did not show any difference in patella tendon length at six months and no difference in pain relief in both groups 3. However this study did not evaluate the functional outcome in both groups.

To our knowledge, there are no RCT looking at the effect of the excision or preservation of the fat pad in TKR and the functional outcomes post operatively.

Study Hypothesis:

Excision of Hoffa's fat pad during total knee replacement surgery does not affect functional outcome, pain level after surgery or the patella tendon length at either one or two years.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Broadgreen Hospital

Liverpool, United Kingdom

About this study

RCT of excision or preservation of fat pad in TKR and the functional outcomes post operatively

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 1- Primary total knee replacement for knee osteoarthritis

Exclusion criteria

  • Revision Surgery.
  • Primary Knee Replacement for pathologies other than Osteoarthritis.
  • Previous knee fractures around the knee.
  • Previous confirmed intra-articular infections.
  • Non English speaking/reading patients.

Treatment and study plan

removal of fat pad

Procedure

Removal removal of fat pad

non removal of fat pad

Procedure

non removal of fat pad

Primary outcomes

  1. Koos Knee Score

    Time frame: 3 months post op,

    The Knee Injury and Osteoarthritis Outcome Score (KOOS) is a knee-specific instrument, developed to assess the patients' opinion about their knee and associated problems. The KOOS evaluates both short-term and long-term consequences of knee injury.

Sponsors and collaborators

Lead sponsor

Liverpool University Hospitals NHS Foundation Trust

Other Gov

Registry information

Official study title

Effect of Excision of the Fat Pad in Total Knee Replacement Surgery. A Randomised Controlled Trial

Important dates

Study start
2012
Primary completion
2022
Study completion
2022
First posted
Aug 7, 2020
Registry last updated
Feb 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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