Lateral Retinacular Release in Total Knee Arthroplasty With Patellar Replacement

NCT ID: NCT05778539

Last Updated: 2023-03-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

220 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-01

Study Completion Date

2022-04-30

Brief Summary

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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

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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.

Conditions

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Anterior Knee Pain Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Lateral retinacular release group

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

Group Type EXPERIMENTAL

Lateral retinacular release

Intervention Type PROCEDURE

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

Non-release group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Lateral retinacular release

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital del Mar

OTHER

Sponsor Role lead

Responsible Party

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Carlos Torrens

Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Parc de Salut Mar

Barcelona, , Spain

Site Status

Countries

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Spain

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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2019/8993/I

Identifier Type: -

Identifier Source: org_study_id

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