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Total Fat Pad Excision Leads to Worse Isokinetic Performance in Total Knee Arthroplasty

Primary Purpose

Osteoarthritis, Knee, Knee Arthritis

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Total infrapatellar fat pad excision
Partial infrapatellar fat pad excision
Sponsored by
Aksaray University Training and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis, Knee focused on measuring Infrapatellar fat pad, Total knee arthroplasty, Isokinetic test, Strength

Eligibility Criteria

55 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Aksaray University Training and Research Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Total infrapatellar fat pad excision group

Partial infrapatellar fat pad excision group

Arm Description

Infrapatellar fat pad was totally excised during total knee arthroplasty in patients randomized to this group.

Infrapatellar fat pad was partially excised during total knee arthroplasty in patients randomized to this group.

Outcomes

Primary Outcome Measures

Peak knee extensor torque change from baseline to postoperative 12 months
Change in peak knee extensor torque from baseline (preoperatively) to 12 months post implantation was evaluated for the operated knee under the supervision of the same physiatrist. The Isokinetic measurements were performed using a Biodex System III Isokinetic Dynamometer, version 3.03 (Biodex Medical Inc.,Shirley, NY, USA). Concentric isokinetic knee flexion-extensions were assessed at a preset velocity of 60º/sec, over a range of motion of 0º to 110º for both parameters. A fixed number of 10 flexion-extension repetitions was completed by each patient. Torque was assessed in Newton-meters (N m).
Peak knee flexor torque change from baseline to postoperative 12 months
Change in peak knee flexor torque from baseline (preoperatively) to 12 months post implantation was evaluated for the operated knee under the supervision of the same physiatrist. The Isokinetic measurements were performed using a Biodex System III Isokinetic Dynamometer, version 3.03 (Biodex Medical Inc.,Shirley, NY, USA). Concentric isokinetic knee flexion-extensions were assessed at a preset velocity of 60º/sec, over a range of motion of 0º to 110º for both parameters. A fixed number of 10 flexion-extension repetitions was completed by each patient. Torque was assessed in Newton-meters (N m).

Secondary Outcome Measures

Knee Society Score (KSS) change from baseline to postoperative 12 months
Change in the Knee Society Score from baseline (preoperatively) to 12 months post implantation was evaluated. The Knee Society Score (KSS) is comprised to two sections (each worth 100 points) for a maximum 200 points. One section is the Knee Society Clinical Score (KSCS) - points are given for pain, motion, and stability and points are deducted for flexion contracture, extension lag, and misalignment. The other section is the Knee Society Functional Score (KSFS) - points are assigned for walking distances and climbing stairs and points are deducted for use of walking aids. For each section, a score of 80-100 = excellent, 70-79 = good; 60-69 = fair; and < 60 = poor.

Full Information

First Posted
June 1, 2020
Last Updated
June 3, 2020
Sponsor
Aksaray University Training and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04419142
Brief Title
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

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
July 5, 2017 (Actual)
Primary Completion Date
October 24, 2018 (Actual)
Study Completion Date
October 24, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aksaray University Training and Research Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee, Knee Arthritis
Keywords
Infrapatellar fat pad, Total knee arthroplasty, Isokinetic test, Strength

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
ParticipantInvestigator
Masking Description
Patients and physiatrists performing isokinetic measurements were blinded to group allocation.
Allocation
Randomized
Enrollment
72 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Total infrapatellar fat pad excision group
Arm Type
Experimental
Arm Description
Infrapatellar fat pad was totally excised during total knee arthroplasty in patients randomized to this group.
Arm Title
Partial infrapatellar fat pad excision group
Arm Type
Experimental
Arm Description
Infrapatellar fat pad was partially excised during total knee arthroplasty in patients randomized to this group.
Intervention Type
Procedure
Intervention Name(s)
Total infrapatellar fat pad excision
Intervention Description
Exposure for total knee arthroplasty (TKA) commonly includes total excision of the infrapatellar fat pad (IPFP). The rationale behind this is to obtain improved access to the lateral tibial plateau allowing a more accurate bone cut, baseplate placement and easier management of soft tissue interposition in the bone and cement interface. However, there is growing concern that as the IPFP is a highly vascularized and innervated fibrous adipose tissue filling the anterior compartment of the knee, its complete excision may have a detrimental effect on knee biomechanics and ultimately, TKA outcome. The reason for this effect has been suggested to be patellar tendon (PT) scarring and shortening via ischemic contracture following impaired vascularization, maintenance and biological repair of the tendon.
Intervention Type
Procedure
Intervention Name(s)
Partial infrapatellar fat pad excision
Intervention Description
It has been suggested in the literature that partial infrapatellar fat pad excision instead of total excision would diminish the potential negative effect on patellar tendon and knee biomechanics. However, there is only limited data in the literature and choice of total/partial infrapatellar fat pad excision in TKA remains debatable.
Primary Outcome Measure Information:
Title
Peak knee extensor torque change from baseline to postoperative 12 months
Description
Change in peak knee extensor torque from baseline (preoperatively) to 12 months post implantation was evaluated for the operated knee under the supervision of the same physiatrist. The Isokinetic measurements were performed using a Biodex System III Isokinetic Dynamometer, version 3.03 (Biodex Medical Inc.,Shirley, NY, USA). Concentric isokinetic knee flexion-extensions were assessed at a preset velocity of 60º/sec, over a range of motion of 0º to 110º for both parameters. A fixed number of 10 flexion-extension repetitions was completed by each patient. Torque was assessed in Newton-meters (N m).
Time Frame
Preoperative - Postoperative 12 months
Title
Peak knee flexor torque change from baseline to postoperative 12 months
Description
Change in peak knee flexor torque from baseline (preoperatively) to 12 months post implantation was evaluated for the operated knee under the supervision of the same physiatrist. The Isokinetic measurements were performed using a Biodex System III Isokinetic Dynamometer, version 3.03 (Biodex Medical Inc.,Shirley, NY, USA). Concentric isokinetic knee flexion-extensions were assessed at a preset velocity of 60º/sec, over a range of motion of 0º to 110º for both parameters. A fixed number of 10 flexion-extension repetitions was completed by each patient. Torque was assessed in Newton-meters (N m).
Time Frame
Preoperative - Postoperative 12 months
Secondary Outcome Measure Information:
Title
Knee Society Score (KSS) change from baseline to postoperative 12 months
Description
Change in the Knee Society Score from baseline (preoperatively) to 12 months post implantation was evaluated. The Knee Society Score (KSS) is comprised to two sections (each worth 100 points) for a maximum 200 points. One section is the Knee Society Clinical Score (KSCS) - points are given for pain, motion, and stability and points are deducted for flexion contracture, extension lag, and misalignment. The other section is the Knee Society Functional Score (KSFS) - points are assigned for walking distances and climbing stairs and points are deducted for use of walking aids. For each section, a score of 80-100 = excellent, 70-79 = good; 60-69 = fair; and < 60 = poor.
Time Frame
Preoperative - Postoperative 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Deniz Çankaya, MD
Organizational Affiliation
Aksaray University Training and Research Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aksaray University Training and Research Hospital
City
Aksaray
ZIP/Postal Code
68200
Country
Turkey

12. IPD Sharing Statement

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Total Fat Pad Excision Leads to Worse Isokinetic Performance in Total Knee Arthroplasty

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