Lateral Retinacular Release in Total Knee Arthroplasty With Patellar Replacement

Anterior Knee Pain Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05778539
• Other study ID #: 2019/8993/I
• Status: Completed
• Phase: N/A
• Start date: October 1, 2019
• Est. completion date: April 30, 2022

Study information

• Verified date: March 2023
• Source: Hospital del Mar
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 220
• Est. completion date: April 30, 2022
• Est. primary completion date: April 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Anterior Knee Pain Syndrome
• Patellofemoral Pain Syndrome

Intervention

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

Locations

Country	Name	City	State
Spain	Parc de Salut Mar	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Hospital del Mar

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Primary	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
Primary	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	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
Secondary	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