Clinical and Instrumental Assessment and Evaluation of Return to Sport in Patients Who Underwent Surgical Treatment for Posterolateral Corner (PLC) Injuries Associated With Anterior Cruciate Ligament (ACL) Injuries. (PAPE_OTT)
This is a single-centre, observational retrospective and prospective study aimed at evaluating the clinical and functional outcomes of patients who underwent combined anterior cruciate ligament (ACL) and posterolateral corner (PLC) reconstruction using the Over-The-Top (OTT) technique.
The primary outcome is the improvement in knee function, assessed using the Lysholm Knee Score by comparing pre-injury/preoperative status with postoperative follow-up. Secondary outcomes include knee stability, assessed through clinical examinations and instrumental measurements (KT-1000, KiRA, PIVOT App and Telos stress radiographs), return to sport, pain, MRI findings and postoperative complications.
Patients aged 18-65 years with a minimum follow-up of 24 months will be included. The study aims to provide evidence on the effectiveness of the combined ACL and PLC reconstruction using the OTT technique.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Studientyp
Einschreibung (Geschätzt)
Kontakte und Standorte
Studienkontakt
- Name: Stefano Zaffagnini
- Telefonnummer: 0516366075
- E-Mail: stefano.zaffagnini@ior.it
Studienorte
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Bologna
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Bologna, Bologna, Italien, 40136
- IRCCS Rizzoli Orthopedic Institute
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Kontakt:
- Stefano Zaffagnini
- Telefonnummer: 0516366075
- E-Mail: stefano.zaffagnini@ior.it
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Probenahmeverfahren
Studienpopulation
Patients will be recruited from both male and female individuals aged between 18 and 65 years (inclusive) at the time of surgery, presenting with combined anterior cruciate ligament (ACL) and posterolateral corner (PLC) injuries of the knee, who underwent surgical treatment at the II Orthopaedic and Traumatologic Clinic of the Rizzoli Orthopaedic Institute. Surgical treatment consisted of ACL reconstruction using the Over-The-Top (OTT) technique combined with posterolateral corner reconstruction, performed between January 1, 2017, and December 31, 2025.
Only patients with a minimum follow-up of 24 months from the date of surgery will be enrolled.
Beschreibung
Inclusion Criteria
- Male and female patients;
- Patients aged between 18 and 65 years at the time of surgery;
- Patients who underwent anterior cruciate ligament (ACL) reconstruction using the Over-The-Top (OTT) technique combined with posterolateral corner (PLC) reconstruction;
- Patients who underwent surgery between January 1, 2017, and December 31, 2025;
- Patients who underwent preoperative imaging examinations (MRI and, if applicable, X-rays) of the affected knee confirming the diagnosis of ACL and posterolateral corner injuries;
- Patients who underwent isolated ACL + PLC reconstruction or ACL + PLC reconstruction combined with additional procedures on the same knee (e.g., meniscal treatment or concomitant ligament injuries);
- Patients who provided written informed consent to participate in the study.
Exclusion Criteria
- History of fractures of the same limb requiring surgical treatment;
- History of posterolateral corner (PLC) injuries of the knee requiring surgical treatment;
- Patients younger than 18 years or older than 65 years at the time of surgery;
- Patients who did not provide informed consent;
- Patients who are no longer contactable.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Beobachtungsmodelle: COHORT
- Zeitperspektiven: CROSS_SECTIONAL
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Lysholm Knee Score
Zeitfenster: Minimum 24 months
|
The Lysholm Knee Score is a validated assessment tool used to evaluate knee function through 8 items addressing the knee's ability to meet the functional demands of daily activities. It is commonly used to assess surgical outcomes in patients undergoing treatment for knee ligament or meniscal injuries. The total score is calculated by summing the scores of the individual items, ranging from 0 to 100. Scores are classified as follows: Excellent (95-100), Good (84-94), Fair (65-83), and Poor (<64). |
Minimum 24 months
|
Mitarbeiter und Ermittler
Sponsor
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Geschätzt)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Andere Studien-ID-Nummern
- PAPE_OTT
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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