Lateral Retinacular Release in Total Knee Arthroplasty With Patellar Replacement

Systematic Lateral Retinacular Release Does Not Reduce Post-Operative Anterior Knee Pain After Primary Total Knee Arthroplasty With Patellar Replacement

The aim of this study is to assess the effect of systematic lateral retinacular release on anterior knee pain, as well as its impact on the functional and radiological outcomes after total knee arthroplasty with patellar resurfacing.

Study Overview

• Status: Completed
• Conditions: Anterior Knee Pain Syndrome
• Intervention / Treatment: Procedure: Lateral retinacular release

Detailed Description

Anterior knee pain is an important cause of persistent pain after total knee arthroplasty. Lateral retinacular release has been proposed as a procedure to prevent anterior knee pain syndrome, based on the reduction of lateral tension and improving patellar tracking.

However, its effect on anterior knee pain after total knee arthroplasty is not clear when it is not strictly needed to correct maltracking.

The purpose of this trial is to evaluate the effect of systematic lateral retinaculare release on anterior knee pain, peformed during a total knee arthroplasty with patellar resurfacing.

• Study Type: Interventional
• Enrollment (Actual): 220
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain, 08003
    • Parc de Salut Mar

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• diagnosis of knee osteoarthritis

Exclusion Criteria:

• prior major surgery on the same knee (high tibial or distal femoral osteotomy, patellar realignment)
• important preoperative malalignment (varus or valgus >15º or flexion deformity >15º)
• inability to sign informed consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lateral retinacular release group; During the implantation of a total knee arthroplasty a lateral retinacular release is performed	Procedure: Lateral retinacular release; During the implantation of a total knee arthroplasty a lateral retinacular release is performed in the intervention group
No Intervention: Non-release group; No aditional gesture in the lateral retinaculum is performed during the implantation of a total knee arthroplasty

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in Anterior Knee Pain at one year after surgery	Pressure pain threshold determined using pressure algometry	At the preoperative visit and at the 1-year follow up
Change from baseline in Knee Pain measured by Visual Analogue Scale at one year after surgery	The Visual Analogue Scale referred by the patients at rest, when walking and when going up and downstairs. Scored between 0 (no pain at all) and 10 (maximum pain the patient could imagine).	At the preoperative visit and at the 1-year follow up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in patellar pain and function at one year after surgery	Patellofemoral score designed by Feller, distributed with a maximum of 15 points for the intensity of anterior knee pain, 5 points for quadriceps strength, 5 points for the ability to rise from a chair and 5 points for stair climbing ability	At the preoperative visit and at the 1-year follow up
Change from baseline in knee fuction, measured by the Knee Society Score, at one year after surgery	The Knee Society Score, being 0 the worst and 100 the best possible result	At the preoperative visit and at the 1-year follow up

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in Patelar Height at one year after surgery	Measured in the lateral radiographic view using the Caton-Deschamps index	At the preoperative visit and at the 1-year follow up
Change from baseline in Patellar Tilt at one year after surgery	Measured in the axial radiographic view, as the angle subtended by the anterior intercondylar line and the equatorial line of the patella preoperatively or a line drawn through the prosthesis-bone interface postoperatively	At the preoperative visit and at the 1-year follow up

Collaborators and Investigators

• Sponsor: Hospital del Mar

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2019
• Primary Completion (Actual): April 30, 2022
• Study Completion (Actual): April 30, 2022

Study Registration Dates

• First Submitted: February 27, 2023
• First Submitted That Met QC Criteria: March 9, 2023
• First Posted (Actual): March 21, 2023

Study Record Updates

• Last Update Posted (Actual): March 21, 2023
• Last Update Submitted That Met QC Criteria: March 9, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Total knee arthroplasty; Anterior knee pain; Patellar resurfacing; Lateral retinacular release
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Patellofemoral Pain Syndrome
• Other Study ID Numbers: 2019/8993/I

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No