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Completed

NCT Number: NCT05778539

Lateral Retinacular Release in 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.

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Key information

Conditions

Anterior Knee Pain Syndrome Joint Diseases Musculoskeletal Diseases Patellofemoral Pain Syndrome

Age range

40 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Parc de Salut Mar

Barcelona, 08003, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lateral retinacular release

Procedure

During the implantation of a total knee arthroplasty a lateral retinacular release is performed in the intervention group

Primary outcomes

  1. Change from baseline in Anterior Knee Pain at one year after surgery

    Time frame: At the preoperative visit and at the 1-year follow up

    Pressure pain threshold determined using pressure algometry

  2. Change from baseline in Knee Pain measured by Visual Analogue Scale at one year after surgery

    Time frame: At the preoperative visit and at the 1-year follow up

    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).

Secondary outcomes

  1. Change from baseline in patellar pain and function at one year after surgery

    Time frame: At the preoperative visit and at the 1-year follow up

    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

  2. Change from baseline in knee fuction, measured by the Knee Society Score, at one year after surgery

    Time frame: At the preoperative visit and at the 1-year follow up

    The Knee Society Score, being 0 the worst and 100 the best possible result

Other outcomes

  1. Change from baseline in Patelar Height at one year after surgery

    Time frame: At the preoperative visit and at the 1-year follow up

    Measured in the lateral radiographic view using the Caton-Deschamps index

  2. Change from baseline in Patellar Tilt at one year after surgery

    Time frame: At the preoperative visit and at the 1-year follow up

    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

Sponsors and collaborators

Lead sponsor

Hospital del Mar

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Mar 21, 2023
Registry last updated
Mar 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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