NCT05778539

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
220

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2019

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2022

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

February 27, 2023

Completed
22 days until next milestone

First Posted

Study publicly available on registry

March 21, 2023

Completed
Last Updated

March 21, 2023

Status Verified

March 1, 2023

Enrollment Period

2.6 years

First QC Date

February 27, 2023

Last Update Submit

March 9, 2023

Conditions

Anterior Knee Pain Syndrome

Keywords

Total knee arthroplastyPatellar resurfacingLateral retinacular releaseAnterior knee pain

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (2)

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

    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

    At the preoperative visit and at the 1-year follow up

Other Outcomes (2)

  • Change from baseline in Patelar Height at one year after surgery

    At the preoperative visit and at the 1-year follow up

  • Change from baseline in Patellar Tilt at one year after surgery

    At the preoperative visit and at the 1-year follow up

Study Arms (2)

Lateral retinacular release group

EXPERIMENTAL

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

Procedure: Lateral retinacular release

Non-release group

NO INTERVENTION

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

Interventions

Lateral retinacular releasePROCEDURE

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

Lateral retinacular release group

Eligibility Criteria

Age40 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • diagnosis of knee osteoarthritis

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Parc de Salut Mar

Barcelona, 08003, Spain

Location

MeSH Terms

Conditions

Patellofemoral Pain Syndrome

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

February 27, 2023

First Posted

March 21, 2023

Study Start

October 1, 2019

Primary Completion

April 30, 2022

Study Completion

April 30, 2022

Last Updated

March 21, 2023

Record last verified: 2023-03

Locations

ES(1)