Surgical Excision of the Fat Pad

Osteo Arthritis Knee Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04503512
• Other study ID #: 4263
• Status: Completed
• Phase: N/A
• Start date: October 23, 2012
• Est. completion date: September 1, 2022

Study information

• Verified date: June 2023
• Source: Liverpool University Hospitals NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 154
• Est. completion date: September 1, 2022
• Est. primary completion date: September 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Osteo Arthritis Knee
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Procedure:
• removal of fat pad
Removal removal of fat pad
• non removal of fat pad
non removal of fat pad

Locations

Country	Name	City	State
United Kingdom	Broadgreen Hospital	Liverpool

Sponsors (1)

Lead Sponsor	Collaborator
Liverpool University Hospitals NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	3 months post op,