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

NCT04419142 | Completed

• 1 other identifier: 1464/2017
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis, Knee; Knee Arthritis

Keywords

Infrapatellar fat pad; Total knee arthroplasty; Isokinetic test; Strength

Outcome Measures

Primary Outcomes (2)

• 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).

  Preoperative - Postoperative 12 months

• 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).

  Preoperative - Postoperative 12 months

Secondary Outcomes (1)

• Knee Society Score (KSS) change from baseline to postoperative 12 months

  Preoperative - Postoperative 12 months

Study Arms (2)

Total infrapatellar fat pad excision group

EXPERIMENTAL

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

Procedure: Total infrapatellar fat pad excision

Partial infrapatellar fat pad excision group

EXPERIMENTAL

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

Procedure: Partial infrapatellar fat pad excision

Interventions

Total infrapatellar fat pad excision PROCEDURE

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.

Total infrapatellar fat pad excision group

Partial infrapatellar fat pad excision PROCEDURE

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.

Partial infrapatellar fat pad excision group

Eligibility Criteria

• Age: 55 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Aksaray University Training and Research Hospital: lead

Study Sites (1)

Aksaray University Training and Research Hospital

Aksaray, 68200, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Deniz Çankaya, MD

  Aksaray University Training and Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Patients and physiatrists performing isokinetic measurements were blinded to group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Co-Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: June 1, 2020
• First Posted: June 5, 2020
• Study Start: July 5, 2017
• Primary Completion: October 24, 2018
• Study Completion: October 24, 2018
• Last Updated: June 5, 2020

Record last verified: 2020-06

Locations

TU (1)