Posterior Cruciate Ligament TearNCT05701592
Assessment of Outcomes of Double-bundle Posterior Cruciate Ligament Reconstruction (DB-PCLR)
An observational study of Posterior Cruciate Ligament Tear, run by Konrad Malinowski MD at 1 site in Poland.
Trial summary
Double-bundle Posterior Cruciate Ligament Reconstruction (DB-PCLR) is becoming increasingly used alternative to the single-bungle PCLR. While more technically challenging, it seems to better improve patients' outcomes. Therefore, outcomes of DB-PCLR will be assessed and reported. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Posterior Cruciate Ligament Tear
- What is being tested?
- DB-PCLR
- Type of treatment
- Surgery or procedure
- How many people
- 10 participants
- Where
- 1 sitePoland
- Study dates
- 20 Dec 2022to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: Patients after PCL tear with knee instability undergoing DB-PCLR
Who may be able to join
- PCL tear with III grade sympomatic posterior instability confirmed clinically and radiologically
- full knee range of motion
Who cannot join
- active knee inflammation
- non-adherence to the study protocol
- fixed posterior drawer
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Poland1 site, 1 recruiting
- Recruiting
Artromedical Orthopaedic Clinic
Bełchatów, Łódź Voivodeship, 97-400
Konrad Malinowski, MD PhD, +48 509 812 212, malwin8@wp.pl
About this study
Double-bundle Posterior Cruciate Ligament Reconstruction (DB-PCLR) is becoming increasingly used alternative to the single-bungle PCLR. While more technically challenging, it seems to better improve patients' outcomes. Therefore, outcomes of DB-PCLR will be assessed and reported.
- Conditions
- Posterior Cruciate Ligament Tear
- Being tested
- DB-PCLR
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DB-PCLRProcedure or surgery
DB-PCLR with reconstruction of both PCL bundles: anterolateral and posteromedial bundle will be performed.
| Study group | Role | What they receive |
|---|---|---|
| Patients with PCL tear treated with DB-PCLR | Patients with PCL tear treated with DB-PCLR Receives: Procedure: DB-PCLR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee posterior translatory stability - posterior sag test
Posterior sag test will be performed and outcome will be presented as present/ absent
Measured: At the 12 month of the follow-up.
Knee posterior translatory stability - posterior drawer test
Posterior drawer test aided with Rollimeter will be performed and outcomes will be presented in milimeters
Measured: At the 12 month of the follow-up.
Knee posterior translatory stability - posterior Lachman test
Posterior Lachman test aided with Rollimeter will be performed and outcomes will be presented in milimeters
Measured: At the 12 month of the follow-up.
Knee posterior translatory stability - stress X-ray
Stress X-ray assessing posterior translatory stability of the knee will be performed and outcomes will be presented in milimeters
Measured: At the 12 month of the follow-up.
Knee internal rotation stability
Maximal knee internal rotation angle will be assessed with different angles of knee flexion and measured by the means of goniometer and outcomes will be presented in degrees
Measured: At the 12 month of the follow-up.
Knee posterior translatory stability - posterior sag test
Posterior sag test will be performed and outcome will be presented as present/ absent
Measured: At the 24 month of the follow-up.
Knee posterior translatory stability - posterior drawer test
Posterior drawer test aided with Rollimeter will be performed and outcomes will be presented in milimeters
Measured: At the 24 month of the follow-up.
Knee posterior translatory stability - posterior Lachman test
Posterior Lachman test aided with Rollimeter will be performed and outcomes will be presented in milimeters
Measured: At the 24 month of the follow-up.
Knee posterior translatory stability - stress X-ray
Stress X-ray assessing posterior translatory stability of the knee will be performed and outcomes will be presented in milimeters
Measured: At the 24 month of the follow-up.
Knee internal rotation stability
Maximal knee internal rotation angle will be assessed with different angles of knee flexion and measured by the means of goniometer and outcomes will be presented in degrees
Measured: At the 24 month of the follow-up.
Secondary outcomes (8)
The functional assessment with the The International Knee Documentation Committee Questionnaire (IKDC)
Min of 0 max of 87 points, higher scores mean a better outcome
Measured: At the 12 month of the follow-up.
The functional assessment with the The International Knee Documentation Committee Questionnaire (IKDC)
Min of 0 max of 87 points, higher scores mean a better outcome
Measured: At the 24 month of the follow-up.
The functional assessment with the Knee injury and Osteoarthritis Outcome Score (KOOS)
Min of 0 max of 100 points, higher scores mean a better outcome
Measured: At the 12 month of the follow-up.
The functional assessment with the Knee injury and Osteoarthritis Outcome Score (KOOS)
Min of 0 max of 100 points, higher scores mean a better outcome
Measured: At the 24 month of the follow-up.
Retear rate
Rate of patients with retear of the reconstructed ligament
Measured: At the 12 month of the follow-up.
Retear rate
Rate of patients with retear of the reconstructed ligament
Measured: At the 24 month of the follow-up.
ROM
Knee range of motion assessed by the means of goniometer.
Measured: At the 12 month of the follow-up.
ROM
Knee range of motion assessed by the means of goniometer.
Measured: At the 24 month of the follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2023
- Study start20 Dec 2022
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Posterior Cruciate Ligament TearStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Konrad Malinowski MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Konrad Malinowski MD, Artromedical Konrad Malinowski Clinic
- Investigators
- Konrad Malinowski, MD PhD, Principal investigator, Artromedical Orthopaedic Clinic, Bełchatów, Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05701592
- Sponsor's protocol ID
- 2-pro-ar-2023
- Status last verified
- Jan 2023
- First submitted
- 9 Jan 2023
- Last updated
- 27 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Chahla J, Moatshe G, Cinque ME, Dornan GJ, Mitchell JJ, Ridley TJ, LaPrade RF. Single-Bundle and Double-Bundle Posterior Cruciate Ligament Reconstructions: A Systematic Review and Meta-analysis of 441 Patients at a Minimum 2 Years' Follow-up. Arthroscopy. 2017 Nov;33(11):2066-2080. doi: 10.1016/j.arthro.2017.06.049. Epub 2017 Aug 31.
PubMed 28866340Knapik DM, Gopinatth V, Jackson GR, Chahla J, Smith MV, Matava MJ, Brophy RH. Global variation in isolated posterior cruciate ligament reconstruction. J Exp Orthop. 2022 Oct 9;9(1):104. doi: 10.1186/s40634-022-00541-4.
PubMed 36209443LaPrade RF, Cinque ME, Dornan GJ, DePhillipo NN, Geeslin AG, Moatshe G, Chahla J. Double-Bundle Posterior Cruciate Ligament Reconstruction in 100 Patients at a Mean 3 Years' Follow-up: Outcomes Were Comparable to Anterior Cruciate Ligament Reconstructions. Am J Sports Med. 2018 Jul;46(8):1809-1818. doi: 10.1177/0363546517750855.
PubMed 29953296Bernhardson AS, DePhillipo NN, Aman ZS, Kennedy MI, Dornan GJ, LaPrade RF. Decreased Posterior Tibial Slope Does Not Affect Postoperative Posterior Knee Laxity After Double-Bundle Posterior Cruciate Ligament Reconstruction. Am J Sports Med. 2019 Feb;47(2):318-323. doi: 10.1177/0363546518819786. Epub 2019 Jan 18.
PubMed 30657698
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Outcomes of Double-bundle Posterior Cruciate Ligament Reconstruction (DB-PCLR)
- ClinicalTrials.gov ID
- NCT05701592
- Acronym / sponsor ID
- 2-pro-ar-2023
- Conditions
- Posterior Cruciate Ligament Tear
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Konrad Malinowski MDUniversity, hospital or other
- Study start
- 20 Dec 2022 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 27 Jan 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.
Double-bundle Posterior Cruciate Ligament Reconstruction (DB-PCLR) is becoming increasingly used alternative to the single-bungle PCLR. While more technically challenging, it seems to better improve patients' outcomes. Therefore, outcomes of DB-PCLR will be assessed and reported.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with PCL tear treated with DB-PCLR | – | Procedure: DB-PCLRPatients with PCL tear treated with DB-PCLR |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients after PCL tear with knee instability undergoing DB-PCLR
Key inclusion criteria (2 listed)
- PCL tear with III grade sympomatic posterior instability confirmed clinically and radiologically
- full knee range of motion
Key exclusion criteria (3 listed)
- active knee inflammation
- non-adherence to the study protocol
- fixed posterior drawer
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 |
|---|---|---|
| DB-PCLRDB-PCLR with reconstruction of both PCL bundles: anterolateral and posteromedial bundle will be performed. | Procedure or surgery | Patients with PCL tear treated with DB-PCLR |
Primary outcome
Knee posterior translatory stability - posterior sag test
Time frame: At the 12 month of the follow-up.
Posterior sag test will be performed and outcome will be presented as present/ absent
Knee posterior translatory stability - posterior drawer test
Time frame: At the 12 month of the follow-up.
Posterior drawer test aided with Rollimeter will be performed and outcomes will be presented in milimeters
Knee posterior translatory stability - posterior Lachman test
Time frame: At the 12 month of the follow-up.
Posterior Lachman test aided with Rollimeter will be performed and outcomes will be presented in milimeters
Knee posterior translatory stability - stress X-ray
Time frame: At the 12 month of the follow-up.
Stress X-ray assessing posterior translatory stability of the knee will be performed and outcomes will be presented in milimeters
Knee internal rotation stability
Time frame: At the 12 month of the follow-up.
Maximal knee internal rotation angle will be assessed with different angles of knee flexion and measured by the means of goniometer and outcomes will be presented in degrees
Knee posterior translatory stability - posterior sag test
Time frame: At the 24 month of the follow-up.
Posterior sag test will be performed and outcome will be presented as present/ absent
Knee posterior translatory stability - posterior drawer test
Time frame: At the 24 month of the follow-up.
Posterior drawer test aided with Rollimeter will be performed and outcomes will be presented in milimeters
Knee posterior translatory stability - posterior Lachman test
Time frame: At the 24 month of the follow-up.
Posterior Lachman test aided with Rollimeter will be performed and outcomes will be presented in milimeters
Knee posterior translatory stability - stress X-ray
Time frame: At the 24 month of the follow-up.
Stress X-ray assessing posterior translatory stability of the knee will be performed and outcomes will be presented in milimeters
Knee internal rotation stability
Time frame: At the 24 month of the follow-up.
Maximal knee internal rotation angle will be assessed with different angles of knee flexion and measured by the means of goniometer and outcomes will be presented in degrees
8 secondary outcomes
The functional assessment with the The International Knee Documentation Committee Questionnaire (IKDC)
Time frame: At the 12 month of the follow-up.
The functional assessment with the The International Knee Documentation Committee Questionnaire (IKDC)
Time frame: At the 24 month of the follow-up.
The functional assessment with the Knee injury and Osteoarthritis Outcome Score (KOOS)
Time frame: At the 12 month of the follow-up.
The functional assessment with the Knee injury and Osteoarthritis Outcome Score (KOOS)
Time frame: At the 24 month of the follow-up.
Retear rate
Time frame: At the 12 month of the follow-up.
Retear rate
Time frame: At the 24 month of the follow-up.
ROM
Time frame: At the 12 month of the follow-up.
ROM
Time frame: At the 24 month of the follow-up.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2023.
- Background: PubMed 28866340Chahla J, Moatshe G, Cinque ME, Dornan GJ, Mitchell JJ, Ridley TJ, LaPrade RF. Single-Bundle and Double-Bundle Posterior Cruciate Ligament Reconstructions: A Systematic Review and Meta-analysis of 441 Patients at a Minimum 2 Years' Follow-up. Arthroscopy. 2017 Nov;33(11):2066-2080. doi: 10.1016/j.arthro.2017.06.049. Epub 2017 Aug 31.
- Background: PubMed 36209443Knapik DM, Gopinatth V, Jackson GR, Chahla J, Smith MV, Matava MJ, Brophy RH. Global variation in isolated posterior cruciate ligament reconstruction. J Exp Orthop. 2022 Oct 9;9(1):104. doi: 10.1186/s40634-022-00541-4.
- Background: PubMed 29953296LaPrade RF, Cinque ME, Dornan GJ, DePhillipo NN, Geeslin AG, Moatshe G, Chahla J. Double-Bundle Posterior Cruciate Ligament Reconstruction in 100 Patients at a Mean 3 Years' Follow-up: Outcomes Were Comparable to Anterior Cruciate Ligament Reconstructions. Am J Sports Med. 2018 Jul;46(8):1809-1818. doi: 10.1177/0363546517750855.
- Background: PubMed 30657698Bernhardson AS, DePhillipo NN, Aman ZS, Kennedy MI, Dornan GJ, LaPrade RF. Decreased Posterior Tibial Slope Does Not Affect Postoperative Posterior Knee Laxity After Double-Bundle Posterior Cruciate Ligament Reconstruction. Am J Sports Med. 2019 Feb;47(2):318-323. doi: 10.1177/0363546518819786. Epub 2019 Jan 18.
- Individual participant dataSharing planned: Undecided
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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.
Konrad Malinowski, MD PhD principal investigator
Artromedical Orthopaedic Clinic, Bełchatów, Poland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Posterior Cruciate Ligament Tear, run by Konrad Malinowski MD at 1 site in Poland.
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 2 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: looking for participants now, as of the sponsor's last update on 27 Jan 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 Poland. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Konrad Malinowski, MD PhD (+48 509812212, malwin8@wp.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knee posterior translatory stability - posterior sag test (time frame: At the 12 month of the follow-up.). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05701592, which also lists 4 linked publications.
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 27 Jan 2023.