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

NCT ID: NCT04419142

Last Updated: 2020-06-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-07-05
• Study Completion Date: 2018-10-24

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Total infrapatellar fat pad excision group

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

Group Type: EXPERIMENTAL

Total infrapatellar fat pad excision

Intervention Type: 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.

Partial infrapatellar fat pad excision group

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

Group Type: EXPERIMENTAL

Partial infrapatellar fat pad excision

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 55 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aksaray University Training and Research Hospital

OTHER

Sponsor Role: lead

Responsible Party

Erdem A Sezgin

Co-Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Deniz Çankaya, MD

Role: PRINCIPAL_INVESTIGATOR

Aksaray University Training and Research Hospital

Locations

Aksaray University Training and Research Hospital

Aksaray, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

1464/2017

Identifier Type: -

Identifier Source: org_study_id