Surgical Excision of the Fat Pad

NCT04503512 | Completed DMC

• 1 other identifier: 4263
• Study Type: interventional
• Target: 154
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteo Arthritis Knee

Outcome Measures

Primary Outcomes (1)

• 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,

Study Arms (2)

Non removal of fat pad

ACTIVE COMPARATOR

Non removal of fat pad

Procedure: non removal of fat pad

Removal of fat pad

ACTIVE COMPARATOR

Removal of fat pad

Procedure: removal of fat pad

Interventions

removal of fat pad PROCEDURE

Removal removal of fat pad

Removal of fat pad

non removal of fat pad PROCEDURE

non removal of fat pad

Non removal of fat pad

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Primary total knee replacement for knee osteoarthritis

You may not qualify if:

• 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.

Sponsors & Collaborators

• Liverpool University Hospitals NHS Foundation Trust: lead

Study Sites (1)

Broadgreen Hospital

Liverpool, United Kingdom

Location

Study Officials

• A Howard

  Liverpool University Hospitals NHS Foundation Trust

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2019
• First Posted: August 7, 2020
• Study Start: October 23, 2012
• Primary Completion: September 1, 2022
• Study Completion: September 1, 2022
• Last Updated: February 15, 2024

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)