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Lateral Retinacular Release in Total Knee Arthroplasty With Patellar Replacement

Primary Purpose

Anterior Knee Pain Syndrome

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Lateral retinacular release
Sponsored by
Hospital del Mar
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anterior Knee Pain Syndrome focused on measuring Total knee arthroplasty, Patellar resurfacing, Lateral retinacular release, Anterior knee pain

Eligibility Criteria

40 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Parc de Salut Mar

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Lateral retinacular release group

Non-release group

Arm Description

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

No aditional gesture in the lateral retinaculum is performed during the implantation of a total knee arthroplasty

Outcomes

Primary Outcome Measures

Change from baseline in Anterior Knee Pain at one year after surgery
Pressure pain threshold determined using pressure algometry
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).

Secondary Outcome Measures

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
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

Full Information

First Posted
February 27, 2023
Last Updated
March 9, 2023
Sponsor
Hospital del Mar
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1. Study Identification

Unique Protocol Identification Number
NCT05778539
Brief Title
Lateral Retinacular Release in Total Knee Arthroplasty With Patellar Replacement
Official Title
Systematic Lateral Retinacular Release Does Not Reduce Post-Operative Anterior Knee Pain After Primary Total Knee Arthroplasty With Patellar Replacement
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
October 1, 2019 (Actual)
Primary Completion Date
April 30, 2022 (Actual)
Study Completion Date
April 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital del Mar

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anterior Knee Pain Syndrome
Keywords
Total knee arthroplasty, Patellar resurfacing, Lateral retinacular release, Anterior knee pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
220 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lateral retinacular release group
Arm Type
Experimental
Arm Description
During the implantation of a total knee arthroplasty a lateral retinacular release is performed
Arm Title
Non-release group
Arm Type
No Intervention
Arm Description
No aditional gesture in the lateral retinaculum is performed during the implantation of a total knee arthroplasty
Intervention Type
Procedure
Intervention Name(s)
Lateral retinacular release
Intervention Description
During the implantation of a total knee arthroplasty a lateral retinacular release is performed in the intervention group
Primary Outcome Measure Information:
Title
Change from baseline in Anterior Knee Pain at one year after surgery
Description
Pressure pain threshold determined using pressure algometry
Time Frame
At the preoperative visit and at the 1-year follow up
Title
Change from baseline in Knee Pain measured by Visual Analogue Scale at one year after surgery
Description
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).
Time Frame
At the preoperative visit and at the 1-year follow up
Secondary Outcome Measure Information:
Title
Change from baseline in patellar pain and function at one year after surgery
Description
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
Time Frame
At the preoperative visit and at the 1-year follow up
Title
Change from baseline in knee fuction, measured by the Knee Society Score, at one year after surgery
Description
The Knee Society Score, being 0 the worst and 100 the best possible result
Time Frame
At the preoperative visit and at the 1-year follow up
Other Pre-specified Outcome Measures:
Title
Change from baseline in Patelar Height at one year after surgery
Description
Measured in the lateral radiographic view using the Caton-Deschamps index
Time Frame
At the preoperative visit and at the 1-year follow up
Title
Change from baseline in Patellar Tilt at one year after surgery
Description
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
Time Frame
At the preoperative visit and at the 1-year follow up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Parc de Salut Mar
City
Barcelona
ZIP/Postal Code
08003
Country
Spain

12. IPD Sharing Statement

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Lateral Retinacular Release in Total Knee Arthroplasty With Patellar Replacement

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