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

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ClinicalTrials.gov Identifier: NCT04419142
Recruitment Status : Completed
First Posted : June 5, 2020
Last Update Posted : June 5, 2020
Sponsor:
Information provided by (Responsible Party):
Erdem A Sezgin, Aksaray University Training and Research Hospital

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.


Condition or disease Intervention/treatment Phase
Osteoarthritis, Knee Knee Arthritis Procedure: Total infrapatellar fat pad excision Procedure: Partial infrapatellar fat pad excision Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: Double (Participant, Investigator)
Masking Description: Patients and physiatrists performing isokinetic measurements were blinded to group allocation.
Primary Purpose: Treatment
Official Title: Total Infrapatellar Fat Pad Excision Leads to Worse Isokinetic Performance in Total Knee Arthroplasty: A Randomized Controlled Trial
Actual Study Start Date : July 5, 2017
Actual Primary Completion Date : October 24, 2018
Actual Study Completion Date : October 24, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement

Arm Intervention/treatment
Experimental: Total infrapatellar fat pad excision group
Infrapatellar fat pad was totally excised during total knee arthroplasty in patients randomized to this group.
Procedure: Total infrapatellar fat pad excision
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.

Experimental: Partial infrapatellar fat pad excision group
Infrapatellar fat pad was partially excised during total knee arthroplasty in patients randomized to this group.
Procedure: Partial infrapatellar fat pad excision
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 Measures :
  1. Peak knee extensor torque change from baseline to postoperative 12 months [ Time Frame: Preoperative - 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).

  2. Peak knee flexor torque change from baseline to postoperative 12 months [ Time Frame: Preoperative - 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 :
  1. Knee Society Score (KSS) change from baseline to postoperative 12 months [ Time Frame: Preoperative - 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.




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Ages Eligible for Study:   55 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04419142


Locations
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Turkey
Aksaray University Training and Research Hospital
Aksaray, Turkey, 68200
Sponsors and Collaborators
Aksaray University Training and Research Hospital
Investigators
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Principal Investigator: Deniz Çankaya, MD Aksaray University Training and Research Hospital
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Responsible Party: Erdem A Sezgin, Co-Principal Investigator, Aksaray University Training and Research Hospital
ClinicalTrials.gov Identifier: NCT04419142    
Other Study ID Numbers: 1464/2017
First Posted: June 5, 2020    Key Record Dates
Last Update Posted: June 5, 2020
Last Verified: June 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Erdem A Sezgin, Aksaray University Training and Research Hospital:
Infrapatellar fat pad
Total knee arthroplasty
Isokinetic test
Strength
Additional relevant MeSH terms:
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Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Osteoarthritis
Rheumatic Diseases