Surgical Excision of the Fat Pad

NCT ID: NCT04503512

Last Updated: 2024-02-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

154 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-23

Study Completion Date

2022-09-01

Brief Summary

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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

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

Conditions

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Osteo Arthritis Knee

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Non removal of fat pad

Non removal of fat pad

Group Type ACTIVE_COMPARATOR

non removal of fat pad

Intervention Type PROCEDURE

non removal of fat pad

Removal of fat pad

Removal of fat pad

Group Type ACTIVE_COMPARATOR

removal of fat pad

Intervention Type PROCEDURE

Removal removal of fat pad

Interventions

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removal of fat pad

Removal removal of fat pad

Intervention Type PROCEDURE

non removal of fat pad

non removal of fat pad

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Liverpool University Hospitals NHS Foundation Trust

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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A Howard

Role: STUDY_DIRECTOR

Liverpool University Hospitals NHS Foundation Trust

Locations

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Broadgreen Hospital

Liverpool, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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4263

Identifier Type: -

Identifier Source: org_study_id

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