Plica MediopatellarisNCT02578589
Medial Plica Syndrome of the Knee: Conservative Treatment Versus Arthroscopic Plica Resection - a Randomized Controlled Multicenter Trial
A study testing Plica resection vs conservative treatment in people with Plica Mediopatellaris, run by Regionshospitalet Silkeborg at 2 sites in Denmark.
Trial summary
The purpose of this trial is to evaluate the effect of conservative treatment in comparison to arthroscopic resection of pathological medial plicae of the knee for patients with medial plica syndrome. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Plica Mediopatellaris
- What is being tested?
- Plica resection vs conservative treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 2 sitesDenmark
- Study dates
- Sep 2014to Dec 2020
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged over 18 years
- History of antermedial knee pain
- Palpable medial band in clinical examination or medial plica appearence on MRI
- Absence of all of the following diagnoses: Osteoarthritis, osteochondritis dissecans, meniscal injury, patella subluxation, pes anserinus bursit, patellofemoral pain syndrome
- Given declaration of consent
- Joining a fitness centre for the duration of minimum 3 months at their own expense.
Who cannot join
- Aged under 18 years
- Presence of one or more of the following diagnoses: Osteoarthritis, osteochondritis dissecans, meniscal injury, patella subluxation, pes anserinus bursit, patellofemoral pain syndrome
- Prior surgical intervention, infection, fracture or patellar luxation concerning the relevant knee
- Not willing to join a fitness centre for the duration of minimum 3 months at their own expense
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites, 2 recruiting
- Recruiting
Regionshospital Silkeborg
Silkeborg, 8600
Steffen Sauer, 04531560149, sauer_steven@web.de
- Recruiting
Regionshospitalet Silkeborg
Silkeborg, 8600
Steffen Sauer, 04531560149, sauer_steven@web.de
About this study
The purpose of this trial is to evaluate the effect of conservative treatment in comparison to arthroscopic resection of pathological medial plicae of the knee for patients with medial plica syndrome. The investigators expect conservative treatment to be significantly superior to arthroscopic plica resection with regard to symptom remission and return to prior functional level.
- Conditions
- Plica Mediopatellaris
- Being tested
- Plica resection vs conservative treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plica resection vs conservative treatmentProcedure or surgery
Plica resection vs conservative treatment
| Study group | Role | What they receive |
|---|---|---|
| surgery | Active comparator | Not described Receives: Procedure: Plica resection vs conservative treatment |
| Conservative treatment | Active comparator | Not described Receives: Procedure: Plica resection vs conservative treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lysholm-Scale (Units on a scale)
Difference of minimum 5 points concerning the average scoring outcome on the Lysholm Knee Scoring Scala in favor of patients undergoing conservative treatment in comparison to patients undergoing arthroscopic plica resection at 2 year follow up. Units of measure (Units on a scale)
Measured: 2 years
Secondary outcomes (3)
Kujala-Scale (Units on a scale)
Secondary endpoints: Higher average scoring outcome on the Anterior Knee Pain Scala (Kujala) in favor of patients undergoing conservative treatment in comparison to patients undergoing arthroscopic plica resection at 2 year follow up. Lower average results on Visual Anologue Scale concerning knee pain while walking indicated by patients undergoing conservative treatment in comparison to patients undergoing arthroscopic plica resection at 2 year follow up. Units of measure (Units on a scale)
Measured: 2 years
QOL-Scale (Units on a scale)
Higher average scoring outcome on the Quality of Life Scala (extracted from KOOS) in favor of patients undergoing conservative treatment in comparison to patients undergoing arthroscopic plica resection at 2 year follow up. Units of measure (Units on a scale)
Measured: 2 years
VAS-Scale (Visual Analog Scale for pain) (Units on a scale)
Lower average results on Visual Anologue Scale concerning knee pain while walking indicated by patients undergoing conservative treatment in comparison to patients undergoing arthroscopic plica resection at 2 year follow up. Units of measure (Units on a scale)
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2015 (estimated)
- Study startSep 2014
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plica MediopatellarisStudies 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
- None (open label)
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Regionshospitalet Silkeborg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Steffen Sauer, Regionshospitalet Silkeborg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02578589
- Sponsor's protocol ID
- 280981PM
- Status last verified
- Oct 2017
- First submitted
- 11 Oct 2015
- Last updated
- 9 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medial Plica Syndrome of the Knee: Conservative Treatment Versus Arthroscopic Plica Resection - a Randomized Controlled Multicenter Trial
- ClinicalTrials.gov ID
- NCT02578589
- Acronym / sponsor ID
- 280981PM
- Conditions
- Plica Mediopatellaris
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Regionshospitalet SilkeborgUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 19 Oct 2015 (estimated)
- 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 purpose of this trial is to evaluate the effect of conservative treatment in comparison to arthroscopic resection of pathological medial plicae of the knee for patients with medial plica syndrome. The investigators expect conservative treatment to be significantly superior to arthroscopic plica resection with regard to symptom remission and return to prior functional level.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| surgery | Active comparator | Procedure: Plica resection vs conservative treatment |
| Conservative treatment | Active comparator | Procedure: Plica resection vs conservative treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Aged over 18 years
- History of antermedial knee pain
- Palpable medial band in clinical examination or medial plica appearence on MRI
- Absence of all of the following diagnoses: Osteoarthritis, osteochondritis dissecans, meniscal injury, patella subluxation, pes anserinus bursit, patellofemoral pain syndrome
- Given declaration of consent
Key exclusion criteria (4 listed)
- Aged under 18 years
- Presence of one or more of the following diagnoses: Osteoarthritis, osteochondritis dissecans, meniscal injury, patella subluxation, pes anserinus bursit, patellofemoral pain syndrome
- Prior surgical intervention, infection, fracture or patellar luxation concerning the relevant knee
- Not willing to join a fitness centre for the duration of minimum 3 months at their own expense
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 |
|---|---|---|
| Plica resection vs conservative treatmentPlica resection vs conservative treatment | Procedure or surgery | Conservative treatment, surgery |
Primary outcome
Lysholm-Scale (Units on a scale)
Time frame: 2 years
Difference of minimum 5 points concerning the average scoring outcome on the Lysholm Knee Scoring Scala in favor of patients undergoing conservative treatment in comparison to patients undergoing arthroscopic plica resection at 2 year follow up. Units of measure (Units on a scale)
3 secondary outcomes
Kujala-Scale (Units on a scale)
Time frame: 2 years
QOL-Scale (Units on a scale)
Time frame: 2 years
VAS-Scale (Visual Analog Scale for pain) (Units on a scale)
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2017.
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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Plica resection vs conservative treatment in people with Plica Mediopatellaris, run by Regionshospitalet Silkeborg at 2 sites in Denmark.
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 6 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 9 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Steffen Sauer, MD (004531560149, sauer_steven@web.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lysholm-Scale (Units on a scale) (time frame: 2 years). 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 9 Oct 2017.