search
Back to results

Surgical Excision of the Fat Pad

Primary Purpose

Osteo Arthritis Knee

Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
removal of fat pad
non removal of fat pad
Sponsored by
Liverpool University Hospitals NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteo Arthritis Knee

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 1- Primary total knee replacement for knee osteoarthritis

Exclusion Criteria:

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

Sites / Locations

  • Broadgreen HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Non removal of fat pad

Removal of fat pad

Arm Description

Non removal of fat pad

Removal of fat pad

Outcomes

Primary Outcome Measures

Koos Knee Score
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.

Secondary Outcome Measures

Full Information

First Posted
August 23, 2019
Last Updated
August 4, 2020
Sponsor
Liverpool University Hospitals NHS Foundation Trust
search

1. Study Identification

Unique Protocol Identification Number
NCT04503512
Brief Title
Surgical Excision of the Fat Pad
Official Title
Effect of Excision of the Fat Pad in Total Knee Replacement Surgery. A Randomised Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Unknown status
Study Start Date
October 23, 2012 (Actual)
Primary Completion Date
December 1, 2020 (Anticipated)
Study Completion Date
December 1, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Liverpool University Hospitals NHS Foundation Trust

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
Detailed Description
RCT of excision or preservation of fat pad in TKR and the functional outcomes post operatively

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteo Arthritis Knee

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
154 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Non removal of fat pad
Arm Type
Active Comparator
Arm Description
Non removal of fat pad
Arm Title
Removal of fat pad
Arm Type
Active Comparator
Arm Description
Removal of fat pad
Intervention Type
Procedure
Intervention Name(s)
removal of fat pad
Intervention Description
Removal removal of fat pad
Intervention Type
Procedure
Intervention Name(s)
non removal of fat pad
Intervention Description
non removal of fat pad
Primary Outcome Measure Information:
Title
Koos Knee Score
Description
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.
Time Frame
3 months post op,

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Antony Howard
Email
'anthonyjhoward@aol.com'
First Name & Middle Initial & Last Name or Official Title & Degree
Jo Banks
Email
Joanne.Banks@LiverpoolFT@nhs.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
A Howard
Organizational Affiliation
Liverpool University Hospitals NHS Foundation Trust
Official's Role
Study Director
Facility Information:
Facility Name
Broadgreen Hospital
City
Liverpool
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anthony Howard, PhD
Phone
07769116998

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Surgical Excision of the Fat Pad

We'll reach out to this number within 24 hrs