Anterior Knee Pain SyndromeNCT05778539
Lateral Retinacular Release in Total Knee Arthroplasty With Patellar Replacement
A study testing Lateral retinacular release in people with Anterior Knee Pain Syndrome, run by Hospital del Mar at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 40 to 90 years
- Conditions the study is for
- Anterior Knee Pain Syndrome
- What is being tested?
- Lateral retinacular release
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteSpain
- Study dates
- 1 Oct 2019to 30 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosis of knee osteoarthritis
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Systematic Lateral Retinacular Release Does Not Reduce Post-Operative Anterior Knee Pain After Primary 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.
Read the 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.
- Conditions
- Anterior Knee Pain Syndrome
- Being tested
- Lateral retinacular release
- Keywords
- Total knee arthroplasty, Patellar resurfacing, Lateral retinacular release, Anterior knee pain
- Medical subject headings
- Patellofemoral Pain Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lateral retinacular releaseProcedure or surgery
During the implantation of a total knee arthroplasty a lateral retinacular release is performed in the intervention group
| Study group | Role | What they receive |
|---|---|---|
| Lateral retinacular release group | Experimental | During the implantation of a total knee arthroplasty a lateral retinacular release is performed Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Anterior Knee Pain at one year after surgery
Pressure pain threshold determined using pressure algometry
Measured: 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).
Measured: 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
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
Measured: 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
The Knee Society Score, being 0 the worst and 100 the best possible result
Measured: At the preoperative visit and at the 1-year follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2023
- Study start1 Oct 2019
- Primary completion30 Apr 2022
- Study completion30 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior Knee Pain SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital del Mar
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carlos Torrens, Hospital del Mar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05778539
- Sponsor's protocol ID
- 2019/8993/I
- Status last verified
- Mar 2023
- First submitted
- 27 Feb 2023
- Last updated
- 21 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Systematic Lateral Retinacular Release Does Not Reduce Post-Operative Anterior Knee Pain After Primary Total Knee Arthroplasty With Patellar Replacement
- ClinicalTrials.gov ID
- NCT05778539
- Acronym / sponsor ID
- 2019/8993/I
- Conditions
- Anterior Knee Pain Syndrome
- Keywords
- Total knee arthroplasty, Patellar resurfacing, Lateral retinacular release, Anterior knee pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- Hospital del MarUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 30 Apr 2022 (actual)
- Study completion
- 30 Apr 2022 (actual)
- First posted
- 21 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lateral retinacular release group | Experimental | Procedure: Lateral retinacular releaseDuring the implantation of a total knee arthroplasty a lateral retinacular release is performed |
| Non-release group | No intervention | –No aditional gesture in the lateral retinaculum is performed during the implantation of a total knee arthroplasty |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- diagnosis of knee osteoarthritis
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lateral retinacular releaseDuring the implantation of a total knee arthroplasty a lateral retinacular release is performed in the intervention group | Procedure or surgery | Lateral retinacular release group |
Primary outcome
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
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).
2 secondary outcomes
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lateral retinacular release in people with Anterior Knee Pain Syndrome, run by Hospital del Mar at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2023.