Patellofemoral DislocationNCT04243265
Clinical Study Relating to Patients Undergoing Medial Femoral Patellar Ligament Reconstruction
A study testing MPFL reconstruction with fascia lata allograft in people with Patellofemoral Dislocation, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
Trial summary
The objective of the present study will be to evaluate the clinical patellofemoral joint function (primary endpoint) and radiographically the patellofemoral arthritic degeneration (secondary endpoint) of of MPFL reconstruction with fascia lata allograft at a minimum follow-up of 2, 5 and 10 years in a group of 25… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patellofemoral Dislocation
- What is being tested?
- MPFL reconstruction with fascia lata allograft
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteItaly
- Study dates
- 17 Dec 2015to 17 Aug 2023
- 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
- The potential person is of legal age, capable of providing informed consent and must sign the Informed Consent Form approved by the Ethics Committee (EC).
- Diagnosis of MPFL injury, performed before surgery, documented by Magnetic Resonance Imaging (MRI) of the affected knee.
- Absence of osteochondral lesions larger than 3 cm2 at the baseline.
- The contralateral knee was and is asymptomatic, stable and functional.
- The patient must be physically and mentally inclined and must have completed post-operative rehabilitation according to the protocol provided at the time of discharge.
Who cannot join
- Local or systemic infection
- Knee osteoarthritis documented radiographically at baseline
- Articular cartilage injury greater than grade I of Outerbridge detected during surgery.
- History of anaphylactic reaction.
- Systemic therapy with all types of corticosteroids or immunosuppressants in the 30 days prior to surgery.
- Evidence of osteonecrosis in the involved knee.
Show all 12Show fewer
- History of rheumatoid arthritis, inflammatory arthritis or autoimmune pathologies.
- Neurological pathologies or conditions that the patient is unsuitable for the rehabilitation protocol.
- Untreated meniscal tissue loss greater than 50% at baseline.
- State of pregnancy.
- Obese or with body mass index BMI> 30 kg / m2.
- Association of Trocleoplasty (intervention that produces degenerative changes in the joint in high apercent).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Study Relating to Patients Undergoing Medial Femoral Patellar Ligament Reconstruction (MPFL) With Fascia Lata Allograft: 10-year Follow-up.
The objective of the present study will be to evaluate the clinical patellofemoral joint function (primary endpoint) and radiographically the patellofemoral arthritic degeneration (secondary endpoint) of of MPFL reconstruction with fascia lata allograft at a minimum follow-up of 2, 5 and 10 years in a group of 25 patients.
Read the detailed description
Patellofemoral disorders make up about 20% of all knee pathologies and are often a source of diagnostic and therapeutic doubts for the orthopedic surgeon. In fact, the origin of this type of disorder is multifactorial and they can occur in the form of a large variety of clinical pictures with different penetrance in each patient.
In accordance with the classification of Dejour et al., the instability of the patella can be divided into traumatic and a-traumatic (recurrent or habitual). The latter patients may present a variety of anatomical anomalies that predispose to dislocation: patella hypoplasia, genu recurvatum, conditions of ligament hyperlassity, hypoplastic external femoral condyle, trochlear dysplasia, high patella, torsional defects of the lower limb.
The incidence of patella dislocation is estimated to be 5.8 cases per 100,000 people, with values that become five times higher in patients aged between 10 and 17 years. Conservative treatment is preferable in the first case of acute dislocation, however the recurrence of this episode occurs in a percentage equal to 15 - 44% in these subjects.
Many surgical interventions have been described to correct the various factors that predispose to patellofemoral instability, with variable success rates (72% with the Hauser technique and 93% with the Roux-Goldthwait technique, 73% with that of Fielding et at. and 78% with that of Trillat. after a long follow-up.
On the other hand, Crosby and Insall, Arnbjornsson et al. and Marcacci et al. have demonstrated a similar clinical outcome in long-term controlled studies but an increase in degenerative changes in operated patients compared to patients treated conservatively. This can be explained by the fact that often a single procedure is not sufficient on its own to resolve such a complex pathology, or with the fact that the operations used so far excessively increase the pressures on the patellofemoral cartilage with subsequent arthrosic degeneration.
The medial patello-femoral ligament (MPFL) is one of the main stabilizers of the patella in its movement on the femur; numerous studies have recently shown that this ligament is damaged in almost all cases, thus recognizing the role of structure that most limits the patella in its lateral dislocation to the MPFL (biomechanically speaking about 50 - 60% of the force). Following these studies, the reconstruction of the MPFL as an elective treatment for relapsing patella dislocation has recently been proposed. Currently, countless surgical techniques have been proposed that use various types of grafts: autologous tendons (the first in 1990 from Suganuma et al.), donor tendons (allograft) and synthetic ligaments.
Our team recently developed a minimally invasive MPFL reconstruction technique using an allograft tendon of the fascia lata. The rationale for this technique is to stabilize the patella and limit medium-long term patellofemoral arthritic degeneration by restoring the MPFL in the most anatomical way possible, not using a tubular graft but an aponevrosis with biomechanical characteristics similar to the MPFL native. The MPFL reconstruction can be used alone or in association with the realignment of the extensor system by transposition of the anterior tibial tuberosity, managing to correct most of the recurrent patellofemoral instabilities. Only in very serious particular cases is it necessary perform additional procedures that are more invasive and have a more uncertain clinical result (such as Trocleoplasty).
The objective of the present study will be to evaluate the clinical patellofemoral joint function (primary endpoint) and radiographically the patellofemoral arthritic degeneration (secondary endpoint) of of MPFL reconstruction with fascia lata allograft at a minimum follow-up of 2, 5 and 10 years in a group of 25 patients.
Sample is represented by 25 patients underwent MPFL reconstruction using a minimally invasive technique using a donor-sided fascia tendon (allograft) performed at the Rizzoli Orthopedic Institute between 2011 and 2015 by the team of Prof. Marcacci.
Any concomitant treatments: treatment of associated meniscal lesions (meniscectomy), reconstruction of the anterior cruciate ligament (ACL), realignment of the extensor system by transposition of the anterior tibial tuberosity (intervention by Elmsile-Trillat).
Follow-up visit will be carried out at 2, 5 and 10 years of average follow-up. The "non parametric Wilcoxon" and "paired Student's t-test" tests will be used to determine the changes between the various follow-up intervals in the outcome measurements respectively for the non-parametric variables (Tegner activity level) and for the parametric ones ( SF-12 test, VAS pain test, KOOS test, Kujala test, "tilt" and "sulcus" angles, "Insall-Salvati" report).
The changes between the various follow-up intervals in the objective IKDC score and in the Iwano score will be assessed by means of the "Pearson chi-square test".
All "p values" will be 2-tailed; the significance level will be defined at p ≤ 0.05.
- Conditions
- Patellofemoral Dislocation
- Being tested
- MPFL reconstruction with fascia lata allograft
- Keywords
- Patellofemoral Dislocation, MPFL reconstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MPFL reconstruction with fascia lata allograftProcedure or surgery
Reconstruction of MPFL using a fascia lata allograft. The rationale for this technique is to stabilize the patella and limit medium to long-term patellofemoral arthritic degeneration by restoring the MPFL in the most anatomical way possible, not using a tubular graft but an aponeurosis with biomechanical characteristics similar to the native MPFL. The MPFL reconstruction can be used alone or in association with the realignment of the extensor apparatus by transposition of the anterior tibial tuberosity, managing to correct most of the recurrent patellofemoral instabilities. Only in very serious particular cases is it necessary to perform more invasive additional procedures with a more uncertain clinical result (such as Trocleoplasty).
| Study group | Role | What they receive |
|---|---|---|
| Patients treated with MPFL reconstruction | Experimental | Patients underwent MPFL reconstruction using a minimally invasive technique using a fascia lata allograft performed at the Rizzoli Orthopedic Institute between 2011 and 2015 by the team of Prof. Marcacci.
Clinical and radiographic evaluation will be performed during outpatients visits. Receives: Procedure: MPFL reconstruction with fascia lata allograft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale
It is a straight line with one end (score 0) meaning no pain and the other end (score 10) meaning the worst pain imaginable. A patient marks a point on the line that matches the amount of pain he or she feels.
Measured: 120 months
Short-Form 12
The SF-12 (Short form health survey) is a questionnaire that aims to investigate the perception of individuals' psychophysical conditions. It is taken from a larger version, the SF-36. It is designed to have similar performance to the SF-36, while taking less time to complete.
Two summary scores are reported from the SF-12 - a mental component score (MCS-12) and a physical component score (PCS-12). The scores may be reported as Z-scores (difference compared to the population average, measured in standard deviations). The United States population average PCS-12 and MCS-12 are both 50 points. The United States population standard deviation is 10 points. So each 10 increment of 10 points above or below 50, corresponds to one standard deviation away from the average.
Measured: 120 months
Kujala knee Score
The Kujala score is a 13-item questionnaire for the patient-reported assessment of anterior knee pain. Score interval is between 0 (worse result) 100 points (better result)
Measured: 120 months
Level of Tegner activity
The Tegner activity scale is a one-item score that graded activity based on work and sports activities on a scale of 0 to 10. Zero represents disability because of knee problems and 10 represents national or international level soccer
Measured: 120 months
Objective evaluation of the International Knee Documentation Committee
The International Knee Documentation Committee (IKDC Questionnaire) is a knee-specific patient-reported outcome which contains sections on knee symptoms (7 items), function (2 items), and sports activities (2 items). It's considered to be one of the most reliable outcome reporting tools in its category and was one of the instruments used in the popular MOON study. IKDC has been subjected to rigorous statistical evaluation and has proven to be a valid and responsive patient-reported outcome measure (PROM).
Scores range from 0 points (lowest level of function or highest level of symptoms) to 100 points (highest level of function and lowest level of symptoms).
Measured: 120 months
Secondary outcomes (4)
Degree of patello-femoral arthritic degeneration
The radiographic evaluation involves the execution of 3 radiographic projections of the operated knee (lateral projection, axial projection of patella at 30° of knee flexion and long-leg standing radiographs.
Radiographs will be evaluated by one independent expert radiologist to determine the degree of patello-femoral arthritic degeneration according to the Iwano radiographic scale.
Stage 0 is normal; stage 1 is mild, in which the joint space is at least 3 mm; stage 2 is moderate, in which the joint space is less than 3 mm, but there is no bony contact; stage 3 is severe, in which partial bony contact less than one-quarter of the joint surface is present; and stage 4 is very severe, in which the joint bony surfaces entirely touch each other.
Measured: 120 months
Patellar tilt angle
The tilt angle is defined as the angle subtended by a line joining the medial and lateral edges of the patella and the horizontal, measured on axial projection of patella at 30° of knee flexion.
Measured: 120 months
Sulcus angle
Angle formed between lines joining the highest points of the bony medial and lateral condyles and the lowest bony point of the intercondylar sulcus, measured on axial projection of patella at 30° of knee flexion.
Measured: 120 months
Insall Salvati ratio
The Insall-Salvati ratio or index is the ratio of the patella tendon length respect to the length of the patella.
This can be measured on a lateral knee x-ray, with the knee 30 degrees flexed.
Measured: 120 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2020
- Study start17 Dec 2015
- Primary completion17 Aug 2023
- Study completion17 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for Patellofemoral DislocationStudies of the same condition, open and under way.
- More trials run by Istituto Ortopedico RizzoliThe sponsor's other registered studies.
- 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
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Ortopedico Rizzoli
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stefano Zaffagnini, MD, PhD, Principal investigator, Istituto Ortopedico Rizzoli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04243265
- Sponsor's protocol ID
- MPFL
- Status last verified
- Jun 2025
- First submitted
- 24 Jan 2020
- Last updated
- 4 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Crosby EB, Insall J. Recurrent dislocation of the patella. Relation of treatment to osteoarthritis. J Bone Joint Surg Am. 1976 Jan;58(1):9-13.
PubMed 1249117Arnbjornsson A, Egund N, Rydling O, Stockerup R, Ryd L. The natural history of recurrent dislocation of the patella. Long-term results of conservative and operative treatment. J Bone Joint Surg Br. 1992 Jan;74(1):140-2. doi: 10.1302/0301-620X.74B1.1732244.
PubMed 1732244Chrisman OD, Snook GA, Wilson TC. A long-term prospective study of the Hauser and Roux-Goldthwait procedures for recurrent patellar dislocation. Clin Orthop Relat Res. 1979 Oct;(144):27-30.
PubMed 535237Dejour H, Walch G, Neyret P, Adeleine P. [Dysplasia of the femoral trochlea]. Rev Chir Orthop Reparatrice Appar Mot. 1990;76(1):45-54. French.
PubMed 2140459Desio SM, Burks RT, Bachus KN. Soft tissue restraints to lateral patellar translation in the human knee. Am J Sports Med. 1998 Jan-Feb;26(1):59-65. doi: 10.1177/03635465980260012701.
PubMed 9474403Fielding JW, Liebler WA, Krishne Urs ND, Wilson SA, Puglisi AS. Tibial tubercle transfer: a long-range follow-up study. Clin Orthop Relat Res. 1979 Oct;(144):43-4.
PubMed 535248Hautamaa PV, Fithian DC, Kaufman KR, Daniel DM, Pohlmeyer AM. Medial soft tissue restraints in lateral patellar instability and repair. Clin Orthop Relat Res. 1998 Apr;(349):174-82. doi: 10.1097/00003086-199804000-00021.
PubMed 9584380Hefti F, Muller W, Jakob RP, Staubli HU. Evaluation of knee ligament injuries with the IKDC form. Knee Surg Sports Traumatol Arthrosc. 1993;1(3-4):226-34. doi: 10.1007/BF01560215.
PubMed 8536037Iwano T, Kurosawa H, Tokuyama H, Hoshikawa Y. Roentgenographic and clinical findings of patellofemoral osteoarthrosis. With special reference to its relationship to femorotibial osteoarthrosis and etiologic factors. Clin Orthop Relat Res. 1990 Mar;(252):190-7.
PubMed 2302884Kodraliu G, Mosconi P, Groth N, Carmosino G, Perilli A, Gianicolo EA, Rossi C, Apolone G. Subjective health status assessment: evaluation of the Italian version of the SF-12 Health Survey. Results from the MiOS Project. J Epidemiol Biostat. 2001;6(3):305-16. doi: 10.1080/135952201317080715.
PubMed 11437095Kujala UM, Jaakkola LH, Koskinen SK, Taimela S, Hurme M, Nelimarkka O. Scoring of patellofemoral disorders. Arthroscopy. 1993;9(2):159-63. doi: 10.1016/s0749-8063(05)80366-4.
PubMed 8461073Marcacci M, Zaffagnini S, Iacono F, Visani A, Petitto A, Neri NP. Results in the treatment of recurrent dislocation of the patella after 30 years' follow-up. Knee Surg Sports Traumatol Arthrosc. 1995;3(3):163-6. doi: 10.1007/BF01565476.
PubMed 8821272Monticone M, Ferrante S, Salvaderi S, Rocca B, Totti V, Foti C, Roi GS. Development of the Italian version of the knee injury and osteoarthritis outcome score for patients with knee injuries: cross-cultural adaptation, dimensionality, reliability, and validity. Osteoarthritis Cartilage. 2012 Apr;20(4):330-5. doi: 10.1016/j.joca.2012.01.001. Epub 2012 Jan 10.
PubMed 22285738Outerbridge RE. The etiology of chondromalacia patellae. 1961. Clin Orthop Relat Res. 2001 Aug;(389):5-8. doi: 10.1097/00003086-200108000-00002. No abstract available.
PubMed 11501822Smith TO, Walker J, Russell N. Outcomes of medial patellofemoral ligament reconstruction for patellar instability: a systematic review. Knee Surg Sports Traumatol Arthrosc. 2007 Nov;15(11):1301-14. doi: 10.1007/s00167-007-0390-0. Epub 2007 Aug 8.
PubMed 17684729
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study Relating to Patients Undergoing Medial Femoral Patellar Ligament Reconstruction (MPFL) With Fascia Lata Allograft: 10-year Follow-up.
- ClinicalTrials.gov ID
- NCT04243265
- Acronym / sponsor ID
- MPFL
- Conditions
- Patellofemoral Dislocation
- Keywords
- Patellofemoral Dislocation, MPFL reconstruction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Istituto Ortopedico RizzoliUniversity, hospital or other
- Study start
- 17 Dec 2015 (actual)
- Primary completion
- 17 Aug 2023 (actual)
- Study completion
- 17 Aug 2023 (actual)
- First posted
- 28 Jan 2020 (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 objective of the present study will be to evaluate the clinical patellofemoral joint function (primary endpoint) and radiographically the patellofemoral arthritic degeneration (secondary endpoint) of of MPFL reconstruction with fascia lata allograft at a minimum follow-up of 2, 5 and 10 years in a group of 25 patients.
Detailed description
Patellofemoral disorders make up about 20% of all knee pathologies and are often a source of diagnostic and therapeutic doubts for the orthopedic surgeon. In fact, the origin of this type of disorder is multifactorial and they can occur in the form of a large variety of clinical pictures with different penetrance in each patient.
In accordance with the classification of Dejour et al., the instability of the patella can be divided into traumatic and a-traumatic (recurrent or habitual). The latter patients may present a variety of anatomical anomalies that predispose to dislocation: patella hypoplasia, genu recurvatum, conditions of ligament hyperlassity, hypoplastic external femoral condyle, trochlear dysplasia, high patella, torsional defects of the lower limb.
The incidence of patella dislocation is estimated to be 5.8 cases per 100,000 people, with values that become five times higher in patients aged between 10 and 17 years. Conservative treatment is preferable in the first case of acute dislocation, however the recurrence of this episode occurs in a percentage equal to 15 - 44% in these subjects.
Many surgical interventions have been described to correct the various factors that predispose to patellofemoral instability, with variable success rates (72% with the Hauser technique and 93% with the Roux-Goldthwait technique, 73% with that of Fielding et at. and 78% with that of Trillat. after a long follow-up.
On the other hand, Crosby and Insall, Arnbjornsson et al. and Marcacci et al. have demonstrated a similar clinical outcome in long-term controlled studies but an increase in degenerative changes in operated patients compared to patients treated conservatively. This can be explained by the fact that often a single procedure is not sufficient on its own to resolve such a complex pathology, or with the fact that the operations used so far excessively increase the pressures on the patellofemoral cartilage with subsequent arthrosic degeneration.
The medial patello-femoral ligament (MPFL) is one of the main stabilizers of the patella in its movement on the femur; numerous studies have recently shown that this ligament is damaged in almost all cases, thus recognizing the role of structure that most limits the patella in its lateral dislocation to the MPFL (biomechanically speaking about 50 - 60% of the force). Following these studies, the reconstruction of the MPFL as an elective treatment for relapsing patella dislocation has recently been proposed. Currently, countless surgical techniques have been proposed that use various types of grafts: autologous tendons (the first in 1990 from Suganuma et al.), donor tendons (allograft) and synthetic ligaments.
Our team recently developed a minimally invasive MPFL reconstruction technique using an allograft tendon of the fascia lata. The rationale for this technique is to stabilize the patella and limit medium-long term patellofemoral arthritic degeneration by restoring the MPFL in the most anatomical way possible, not using a tubular graft but an aponevrosis with biomechanical characteristics similar to the MPFL native. The MPFL reconstruction can be used alone or in association with the realignment of the extensor system by transposition of the anterior tibial tuberosity, managing to correct most of the recurrent patellofemoral instabilities. Only in very serious particular cases is it necessary perform additional procedures that are more invasive and have a more uncertain clinical result (such as Trocleoplasty).
The objective of the present study will be to evaluate the clinical patellofemoral joint function (primary endpoint) and radiographically the patellofemoral arthritic degeneration (secondary endpoint) of of MPFL reconstruction with fascia lata allograft at a minimum follow-up of 2, 5 and 10 years in a group of 25 patients.
Sample is represented by 25 patients underwent MPFL reconstruction using a minimally invasive technique using a donor-sided fascia tendon (allograft) performed at the Rizzoli Orthopedic Institute between 2011 and 2015 by the team of Prof. Marcacci.
Any concomitant treatments: treatment of associated meniscal lesions (meniscectomy), reconstruction of the anterior cruciate ligament (ACL), realignment of the extensor system by transposition of the anterior tibial tuberosity (intervention by Elmsile-Trillat).
Follow-up visit will be carried out at 2, 5 and 10 years of average follow-up. The "non parametric Wilcoxon" and "paired Student's t-test" tests will be used to determine the changes between the various follow-up intervals in the outcome measurements respectively for the non-parametric variables (Tegner activity level) and for the parametric ones ( SF-12 test, VAS pain test, KOOS test, Kujala test, "tilt" and "sulcus" angles, "Insall-Salvati" report).
The changes between the various follow-up intervals in the objective IKDC score and in the Iwano score will be assessed by means of the "Pearson chi-square test".
All "p values" will be 2-tailed; the significance level will be defined at p ≤ 0.05.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients treated with MPFL reconstruction | Experimental | Procedure: MPFL reconstruction with fascia lata allograftPatients underwent MPFL reconstruction using a minimally invasive technique using a fascia lata allograft performed at the Rizzoli Orthopedic Institute between 2011 and 2015 by the team of Prof. Marcacci. Clinical and radiographic evaluation will be performed during outpatients visits. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- The potential person is of legal age, capable of providing informed consent and must sign the Informed Consent Form approved by the Ethics Committee (EC).
- Diagnosis of MPFL injury, performed before surgery, documented by Magnetic Resonance Imaging (MRI) of the affected knee.
- Absence of osteochondral lesions larger than 3 cm2 at the baseline.
- The contralateral knee was and is asymptomatic, stable and functional.
- The patient must be physically and mentally inclined and must have completed post-operative rehabilitation according to the protocol provided at the time of discharge.
Key exclusion criteria (12 listed)
- Local or systemic infection
- Knee osteoarthritis documented radiographically at baseline
- Articular cartilage injury greater than grade I of Outerbridge detected during surgery.
- History of anaphylactic reaction.
- Systemic therapy with all types of corticosteroids or immunosuppressants in the 30 days prior to surgery.
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 |
|---|---|---|
| MPFL reconstruction with fascia lata allograftReconstruction of MPFL using a fascia lata allograft. The rationale for this technique is to stabilize the patella and limit medium to long-term patellofemoral arthritic degeneration by restoring the MPFL in the most anatomical way possible, not using a tubular graft but an aponeurosis with biomechanical characteristics similar to the native MPFL. The MPFL reconstruction can be used alone or in association with the realignment of the extensor apparatus by transposition of the anterior tibial tuberosity, managing to correct most of the recurrent patellofemoral instabilities. Only in very serious particular cases is it necessary to perform more invasive additional procedures with a more uncertain clinical result (such as Trocleoplasty). | Procedure or surgery | Patients treated with MPFL reconstruction |
Primary outcome
Visual Analogue Scale
Time frame: 120 months
It is a straight line with one end (score 0) meaning no pain and the other end (score 10) meaning the worst pain imaginable. A patient marks a point on the line that matches the amount of pain he or she feels.
Short-Form 12
Time frame: 120 months
The SF-12 (Short form health survey) is a questionnaire that aims to investigate the perception of individuals' psychophysical conditions. It is taken from a larger version, the SF-36. It is designed to have similar performance to the SF-36, while taking less time to complete. Two summary scores are reported from the SF-12 - a mental component score (MCS-12) and a physical component score (PCS-12). The scores may be reported as Z-scores (difference compared to the population average, measured in standard deviations). The United States population average PCS-12 and MCS-12 are both 50 points. The United States population standard deviation is 10 points. So each 10 increment of 10 points above or below 50, corresponds to one standard deviation away from the average.
Kujala knee Score
Time frame: 120 months
The Kujala score is a 13-item questionnaire for the patient-reported assessment of anterior knee pain. Score interval is between 0 (worse result) 100 points (better result)
Level of Tegner activity
Time frame: 120 months
The Tegner activity scale is a one-item score that graded activity based on work and sports activities on a scale of 0 to 10. Zero represents disability because of knee problems and 10 represents national or international level soccer
Objective evaluation of the International Knee Documentation Committee
Time frame: 120 months
The International Knee Documentation Committee (IKDC Questionnaire) is a knee-specific patient-reported outcome which contains sections on knee symptoms (7 items), function (2 items), and sports activities (2 items). It's considered to be one of the most reliable outcome reporting tools in its category and was one of the instruments used in the popular MOON study. IKDC has been subjected to rigorous statistical evaluation and has proven to be a valid and responsive patient-reported outcome measure (PROM). Scores range from 0 points (lowest level of function or highest level of symptoms) to 100 points (highest level of function and lowest level of symptoms).
4 secondary outcomes
Degree of patello-femoral arthritic degeneration
Time frame: 120 months
Patellar tilt angle
Time frame: 120 months
Sulcus angle
Time frame: 120 months
Insall Salvati ratio
Time frame: 120 months
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 4 Jun 2025.
- Background: PubMed 1249117Crosby EB, Insall J. Recurrent dislocation of the patella. Relation of treatment to osteoarthritis. J Bone Joint Surg Am. 1976 Jan;58(1):9-13.
- Results publication: PubMed 1732244Arnbjornsson A, Egund N, Rydling O, Stockerup R, Ryd L. The natural history of recurrent dislocation of the patella. Long-term results of conservative and operative treatment. J Bone Joint Surg Br. 1992 Jan;74(1):140-2. doi: 10.1302/0301-620X.74B1.1732244.
- Results publication: PubMed 535237Chrisman OD, Snook GA, Wilson TC. A long-term prospective study of the Hauser and Roux-Goldthwait procedures for recurrent patellar dislocation. Clin Orthop Relat Res. 1979 Oct;(144):27-30.
- Results publication: PubMed 2140459Dejour H, Walch G, Neyret P, Adeleine P. [Dysplasia of the femoral trochlea]. Rev Chir Orthop Reparatrice Appar Mot. 1990;76(1):45-54. French.
- Results publication: PubMed 9474403Desio SM, Burks RT, Bachus KN. Soft tissue restraints to lateral patellar translation in the human knee. Am J Sports Med. 1998 Jan-Feb;26(1):59-65. doi: 10.1177/03635465980260012701.
- Results publication: PubMed 535248Fielding JW, Liebler WA, Krishne Urs ND, Wilson SA, Puglisi AS. Tibial tubercle transfer: a long-range follow-up study. Clin Orthop Relat Res. 1979 Oct;(144):43-4.
- Results publication: PubMed 9584380Hautamaa PV, Fithian DC, Kaufman KR, Daniel DM, Pohlmeyer AM. Medial soft tissue restraints in lateral patellar instability and repair. Clin Orthop Relat Res. 1998 Apr;(349):174-82. doi: 10.1097/00003086-199804000-00021.
- Results publication: PubMed 8536037Hefti F, Muller W, Jakob RP, Staubli HU. Evaluation of knee ligament injuries with the IKDC form. Knee Surg Sports Traumatol Arthrosc. 1993;1(3-4):226-34. doi: 10.1007/BF01560215.
- Results publication: PubMed 2302884Iwano T, Kurosawa H, Tokuyama H, Hoshikawa Y. Roentgenographic and clinical findings of patellofemoral osteoarthrosis. With special reference to its relationship to femorotibial osteoarthrosis and etiologic factors. Clin Orthop Relat Res. 1990 Mar;(252):190-7.
- Results publication: PubMed 11437095Kodraliu G, Mosconi P, Groth N, Carmosino G, Perilli A, Gianicolo EA, Rossi C, Apolone G. Subjective health status assessment: evaluation of the Italian version of the SF-12 Health Survey. Results from the MiOS Project. J Epidemiol Biostat. 2001;6(3):305-16. doi: 10.1080/135952201317080715.
- Results publication: PubMed 8461073Kujala UM, Jaakkola LH, Koskinen SK, Taimela S, Hurme M, Nelimarkka O. Scoring of patellofemoral disorders. Arthroscopy. 1993;9(2):159-63. doi: 10.1016/s0749-8063(05)80366-4.
- Results publication: PubMed 8821272Marcacci M, Zaffagnini S, Iacono F, Visani A, Petitto A, Neri NP. Results in the treatment of recurrent dislocation of the patella after 30 years' follow-up. Knee Surg Sports Traumatol Arthrosc. 1995;3(3):163-6. doi: 10.1007/BF01565476.
- Individual participant dataSharing planned: No
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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.
Stefano Zaffagnini, MD, PhD principal investigator
Istituto Ortopedico Rizzoli
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MPFL reconstruction with fascia lata allograft in people with Patellofemoral Dislocation, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
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 5 inclusion and 12 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 4 Jun 2025. 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 Italy. 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?
Visual Analogue Scale (time frame: 120 months). The study lists 5 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 NCT04243265, which also lists 21 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 4 Jun 2025.