Clinical trial NCT04419142: Total Fat Pad Excision Leads to Worse Isokinetic Performance in Total Knee Arthroplasty
Official title: Total Infrapatellar Fat Pad Excision Leads to Worse Isokinetic Performance in Total Knee Arthroplasty: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis, Knee
Knee Arthritis
Keywords: Infrapatellar fat pad
Total knee arthroplasty
Isokinetic test
Strength
Lead sponsor: Aksaray University Training and Research Hospital
Sponsor class: OTHER
First posted: 2020-06-05
Enrollment: 72
Sex: ALL
Minimum age (years): 55
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients were randomized in a 1:1 ratio via computer-generated randomization using Microsoft Excel 2016 (Microsoft Corporation, Seattle, WA, USA) to be allocated in the total or partial infrapatellar fat pad excision group before the TKA operation (Figure 1). Unblinded senior resident implemented the randomization. Patients and physiatrists performing isokinetic measurements were blinded to group allocation.
Primary purpose: TREATMENT

Brief summary: There are concerns that total infrapatellar fat pad (IPFP) excision in total knee arthroplasty (TKA) results in patellar tendon shortening due to ischemic contracture. But, individual preference of the surgeon is still the main determinant between total or partial excision. The aim of this randomized controlled trial is to compare knee society score (KSS), knee extension and flexion peak torque in patients undergoing TKA with total IPFP excision or partial IPFP excision. The hypothesis of the study is that during TKA, total IPFP excision would lead to worse isokinetic performance and clinical outcome.

A total of 72 patients scheduled to undergo TKA for primary osteoarthritis of the knee by a single surgeon were randomly assigned to either the total or partial excision group. Patients were evaluated preoperatively and at postoperative 1 year, with Knee Society Score (KSS) and isokinetic measurements. Physiatrist doing isokinetic tests and patients were blinded to the study.


Eligibility criteria: Inclusion Criteria:

* Age between 55 and 80 years
* Scheduled to undergo unilateral TKA on for primary knee osteoarthritis

Exclusion Criteria:

* Inflammatory arthritis
* Post-traumatic osteoarthritis
* Previous knee surgery
* Neuromuscular diseases
* Bilateral TKA
* Insufficiency of collateral ligaments

Primary outcomes:
measure: Peak knee extensor torque change from baseline to postoperative 12 months
timeFrame: Preoperative - Postoperative 12 months
measure: Peak knee flexor torque change from baseline to postoperative 12 months
timeFrame: Preoperative - Postoperative 12 months
Secondary outcomes:
measure: Knee Society Score (KSS) change from baseline to postoperative 12 months
timeFrame: Preoperative - Postoperative 12 months
Other outcomes:
Locations:
city: Aksaray
country: Turkey
facility: Aksaray University Training and Research Hospital
Study officials:
affiliation: Aksaray University Training and Research Hospital
name: Deniz Çankaya, MD
role: PRINCIPAL_INVESTIGATOR
References: