Lateral Patellofemoral Dislocation Closed TraumaticNCT05868434
MPFLR With Fascia Lata Allograft, Based on Isometry Assessment + Elmslie-Trillat TTO
A study testing Medial Patellofemoral Ligament Reconstruction (MPFLR) With Fascia Lata Allograft, Based on Isometry Assessment Combined With Elmslie-Trillat Tibial Tuberosity Osteotomy. in people with Lateral Patellofemoral Dislocation Closed Traumatic and Lateral Patellar Luxation, run by Artromedical Konrad Malinowski Clinic at 1 site in Poland.
Trial summary
The aim of this study is to assess outcomes of MPFLR With Fascia Lata Allograft, Based on Isometry Assessment Combined With Elmslie-Trillat Tibial Tuberosity Osteotomy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lateral Patellofemoral Dislocation Closed Traumatic, Lateral Patellar Luxation
- What is being tested?
- Medial Patellofemoral Ligament Reconstruction (MPFLR) With Fascia Lata Allograft, Based on Isometry Assessment Combined With Elmslie-Trillat Tibial Tuberosity Osteotomy.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 sitePoland
- Study dates
- 25 Feb 2022to 31 Dec 2026
- Phase
- Interventional
- 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
Who may be able to join
- Lateral patellar dislocation with subsequent instability
- Failure of non-operative treatment
Who cannot join
- Active inflammation of the knee;
- Previous surgeries on the patellofemoral joint;
- Fractures around the knee
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
Official title: Medial Patellofemoral Ligament Reconstruction (MPFLR) With Fascia Lata Allograft, Based on Isometry Assessment Combined With Elmslie-Trillat Tibial Tuberosity Osteotomy.
The aim of this study is to assess outcomes of MPFLR With Fascia Lata Allograft, Based on Isometry Assessment Combined With Elmslie-Trillat Tibial Tuberosity Osteotomy.
Read the detailed description
Medial Patellofemoral Ligament (MPFL) injury occurs in more than 95% of lateral patellar dislocations. Most of these injuries result in subsequent lateral patellar instability. Therefore, MPFL reconstruction (MPFLR) is often necessary. The aim of this study is to assess outcomes of MPFLR With Fascia Lata Allograft, Based on Isometry Assessment Combined With Elmslie-Trillat Tibial Tuberosity Osteotomy.
The primary outcome consists of The International Knee Documentation Committee Questionnaire (IKDC), the Knee injury and Osteoarthritis Outcome Score (KOOS) and retear rate.
- Being tested
- Medial Patellofemoral Ligament Reconstruction (MPFLR) With Fascia Lata Allograft, Based on Isometry Assessment Combined With Elmslie-Trillat Tibial Tuberosity Osteotomy.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medial Patellofemoral Ligament Reconstruction (MPFLR) With Fascia Lata Allograft, Based on Isometry Assessment Combined With Elmslie-Trillat Tibial Tuberosity Osteotomy.Procedure or surgery
Medial Patellofemoral Ligament Reconstruction (MPFLR) With Fascia Lata Allograft, Based on Isometry Assessment Combined With Elmslie-Trillat Tibial Tuberosity Osteotomy. Management of any accompanying patellofemoral lesions will be performed as well.
| Study group | Role | What they receive |
|---|---|---|
| Main arm of the study | Experimental | Medial Patellofemoral Ligament Reconstruction (MPFLR) With Fascia Lata Allograft, Based on Isometry Assessment Combined With Elmslie-Trillat Tibial Tuberosity Osteotomy will be performed in these patients. Receives: Procedure: Medial Patellofemoral Ligament Reconstruction (MPFLR) With Fascia Lata Allograft, Based on Isometry Assessment Combined With Elmslie-Trillat Tibial Tuberosity Osteotomy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lateral patella stability - apprehension test
Apprehension test at 30 degrees of knee flexion
Measured: At the 12 month of the follow-up.
Lateral patella stability - lateral luxation test
Lateral luxation test at 30 degrees of knee flexion
Measured: At the 12 month of the follow-up.
Lateral patella stability - apprehension test
Apprehension test at 30 degrees of knee flexion
Measured: At the 24 month of the follow-up.
Lateral patella stability - lateral luxation test
Lateral luxation test at 30 degrees of knee flexion
Measured: At the 24 month of the follow-up.
Secondary outcomes (6)
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
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
Min of 0 max of 100 points, higher scores mean a better outcome
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 posted22 May 2023
- Study start25 Feb 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 (6)Papers the sponsor has linked to this study.
- Other trials for Lateral Patellofemoral Dislocation Closed TraumaticStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Artromedical Konrad Malinowski Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal 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
- NCT05868434
- Sponsor's protocol ID
- 3-pro-ar-2023
- Status last verified
- May 2023
- First submitted
- 8 May 2023
- Last updated
- 22 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Ryan PC, Ross BJ, Stamm MA, Sherman WF, Heard WMR, Mulcahey MK. Concomitant Tibial Tubercle Osteotomy Reduces the Risk of Revision Surgery After Medial Patellofemoral Ligament Reconstruction for the Treatment of Patellar Instability. Arthroscopy. 2023 Sep;39(9):2037-2045.e1. doi: 10.1016/j.arthro.2023.02.006. Epub 2023 Feb 18.
PubMed 36804459Agarwalla A, Gowd AK, Liu JN, Puzzitiello RN, Yanke AB, Verma NN, Forsythe B. Concomitant Medial Patellofemoral Ligament Reconstruction and Tibial Tubercle Osteotomy Do Not Increase the Incidence of 30-Day Complications: An Analysis of the NSQIP Database. Orthop J Sports Med. 2019 Apr 12;7(4):2325967119837639. doi: 10.1177/2325967119837639. eCollection 2019 Apr.
PubMed 31019984Franciozi CE, Ambra LF, Albertoni LJB, Debieux P, Granata GSM Jr, Kubota MS, Carneiro M, Abdalla RJ, Luzo MVM, Cohen M. Anteromedial Tibial Tubercle Osteotomy Improves Results of Medial Patellofemoral Ligament Reconstruction for Recurrent Patellar Instability in Patients With Tibial Tuberosity-Trochlear Groove Distance of 17 to 20 mm. Arthroscopy. 2019 Feb;35(2):566-574. doi: 10.1016/j.arthro.2018.10.109. Epub 2019 Jan 4.
PubMed 30612771Aliberti GM, Kraeutler MJ, Miskimin C, Scillia AJ, Belk JW, Mulcahey MK. Autograft Versus Allograft for Medial Patellofemoral Ligament Reconstruction: A Systematic Review. Orthop J Sports Med. 2021 Oct 19;9(10):23259671211046639. doi: 10.1177/23259671211046639. eCollection 2021 Oct.
PubMed 34692883Allen MM, Krych AJ, Johnson NR, Mohan R, Stuart MJ, Dahm DL. Combined Tibial Tubercle Osteotomy and Medial Patellofemoral Ligament Reconstruction for Recurrent Lateral Patellar Instability in Patients With Multiple Anatomic Risk Factors. Arthroscopy. 2018 Aug;34(8):2420-2426.e3. doi: 10.1016/j.arthro.2018.02.049. Epub 2018 May 19.
PubMed 29789255Lobner S, Krauss C, Reichwein F, Patzer T, Nebelung W, Venjakob AJ. Surgical treatment of patellar instability: clinical and radiological outcome after medial patellofemoral ligament reconstruction and tibial tuberosity medialisation. Arch Orthop Trauma Surg. 2017 Aug;137(8):1087-1095. doi: 10.1007/s00402-017-2705-z. Epub 2017 May 16.
PubMed 28508959
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medial Patellofemoral Ligament Reconstruction (MPFLR) With Fascia Lata Allograft, Based on Isometry Assessment Combined With Elmslie-Trillat Tibial Tuberosity Osteotomy.
- ClinicalTrials.gov ID
- NCT05868434
- Acronym / sponsor ID
- 3-pro-ar-2023
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Artromedical Konrad Malinowski ClinicUniversity, hospital or other
- Study start
- 25 Feb 2022 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 22 May 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 outcomes of MPFLR With Fascia Lata Allograft, Based on Isometry Assessment Combined With Elmslie-Trillat Tibial Tuberosity Osteotomy.
Detailed description
Medial Patellofemoral Ligament (MPFL) injury occurs in more than 95% of lateral patellar dislocations. Most of these injuries result in subsequent lateral patellar instability. Therefore, MPFL reconstruction (MPFLR) is often necessary. The aim of this study is to assess outcomes of MPFLR With Fascia Lata Allograft, Based on Isometry Assessment Combined With Elmslie-Trillat Tibial Tuberosity Osteotomy.
The primary outcome consists of The International Knee Documentation Committee Questionnaire (IKDC), the Knee injury and Osteoarthritis Outcome Score (KOOS) and retear rate.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Main arm of the study | Experimental | Procedure: Medial Patellofemoral Ligament Reconstruction (MPFLR) With Fascia Lata Allograft, Based on Isometry Assessment Combined With Elmslie-Trillat Tibial Tuberosity Osteotomy.Medial Patellofemoral Ligament Reconstruction (MPFLR) With Fascia Lata Allograft, Based on Isometry Assessment Combined With Elmslie-Trillat Tibial Tuberosity Osteotomy will be performed in these patients. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Lateral patellar dislocation with subsequent instability
- Failure of non-operative treatment
Key exclusion criteria (3 listed)
- Active inflammation of the knee;
- Previous surgeries on the patellofemoral joint;
- Fractures around the knee
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 |
|---|---|---|
| Medial Patellofemoral Ligament Reconstruction (MPFLR) With Fascia Lata Allograft, Based on Isometry Assessment Combined With Elmslie-Trillat Tibial Tuberosity Osteotomy.Medial Patellofemoral Ligament Reconstruction (MPFLR) With Fascia Lata Allograft, Based on Isometry Assessment Combined With Elmslie-Trillat Tibial Tuberosity Osteotomy. Management of any accompanying patellofemoral lesions will be performed as well. | Procedure or surgery | Main arm of the study |
Primary outcome
Lateral patella stability - apprehension test
Time frame: At the 12 month of the follow-up.
Apprehension test at 30 degrees of knee flexion
Lateral patella stability - lateral luxation test
Time frame: At the 12 month of the follow-up.
Lateral luxation test at 30 degrees of knee flexion
Lateral patella stability - apprehension test
Time frame: At the 24 month of the follow-up.
Apprehension test at 30 degrees of knee flexion
Lateral patella stability - lateral luxation test
Time frame: At the 24 month of the follow-up.
Lateral luxation test at 30 degrees of knee flexion
6 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
Time frame: At the 12 month of the follow-up.
The functional assessment with the Knee injury and Osteoarthritis Outcome Score
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 22 May 2023.
- Background: PubMed 36804459Ryan PC, Ross BJ, Stamm MA, Sherman WF, Heard WMR, Mulcahey MK. Concomitant Tibial Tubercle Osteotomy Reduces the Risk of Revision Surgery After Medial Patellofemoral Ligament Reconstruction for the Treatment of Patellar Instability. Arthroscopy. 2023 Sep;39(9):2037-2045.e1. doi: 10.1016/j.arthro.2023.02.006. Epub 2023 Feb 18.
- Background: PubMed 31019984Agarwalla A, Gowd AK, Liu JN, Puzzitiello RN, Yanke AB, Verma NN, Forsythe B. Concomitant Medial Patellofemoral Ligament Reconstruction and Tibial Tubercle Osteotomy Do Not Increase the Incidence of 30-Day Complications: An Analysis of the NSQIP Database. Orthop J Sports Med. 2019 Apr 12;7(4):2325967119837639. doi: 10.1177/2325967119837639. eCollection 2019 Apr.
- Background: PubMed 30612771Franciozi CE, Ambra LF, Albertoni LJB, Debieux P, Granata GSM Jr, Kubota MS, Carneiro M, Abdalla RJ, Luzo MVM, Cohen M. Anteromedial Tibial Tubercle Osteotomy Improves Results of Medial Patellofemoral Ligament Reconstruction for Recurrent Patellar Instability in Patients With Tibial Tuberosity-Trochlear Groove Distance of 17 to 20 mm. Arthroscopy. 2019 Feb;35(2):566-574. doi: 10.1016/j.arthro.2018.10.109. Epub 2019 Jan 4.
- Background: PubMed 34692883Aliberti GM, Kraeutler MJ, Miskimin C, Scillia AJ, Belk JW, Mulcahey MK. Autograft Versus Allograft for Medial Patellofemoral Ligament Reconstruction: A Systematic Review. Orthop J Sports Med. 2021 Oct 19;9(10):23259671211046639. doi: 10.1177/23259671211046639. eCollection 2021 Oct.
- Background: PubMed 29789255Allen MM, Krych AJ, Johnson NR, Mohan R, Stuart MJ, Dahm DL. Combined Tibial Tubercle Osteotomy and Medial Patellofemoral Ligament Reconstruction for Recurrent Lateral Patellar Instability in Patients With Multiple Anatomic Risk Factors. Arthroscopy. 2018 Aug;34(8):2420-2426.e3. doi: 10.1016/j.arthro.2018.02.049. Epub 2018 May 19.
- Background: PubMed 28508959Lobner S, Krauss C, Reichwein F, Patzer T, Nebelung W, Venjakob AJ. Surgical treatment of patellar instability: clinical and radiological outcome after medial patellofemoral ligament reconstruction and tibial tuberosity medialisation. Arch Orthop Trauma Surg. 2017 Aug;137(8):1087-1095. doi: 10.1007/s00402-017-2705-z. Epub 2017 May 16.
- Individual participant dataSharing planned: Undecided
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?
A study testing Medial Patellofemoral Ligament Reconstruction (MPFLR) With Fascia Lata Allograft, Based on Isometry Assessment Combined With Elmslie-Trillat Tibial Tuberosity Osteotomy. in people with Lateral Patellofemoral Dislocation Closed Traumatic and Lateral Patellar Luxation, run by Artromedical Konrad Malinowski Clinic 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 22 May 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?
Lateral patella stability - apprehension test (time frame: At the 12 month of the follow-up.). The study lists 4 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 NCT05868434, which also lists 6 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 22 May 2023.