Evaluating MPFL reconstruction for patellofemoral dislocation

Clinical Study Relating to Patients Undergoing Medial Femoral Patellar Ligament Reconstruction (MPFL) With Fascia Lata Allograft: 10-year Follow-up.

This study is testing if surgery to reconstruct a knee ligament can improve joint function and reduce arthritis in people who have had their kneecap dislocate.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 25 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Istituto Ortopedico Rizzoli (Academic / other)
• Locations: 1 site (Bologna)
• Trial ID: NCT04243265 on ClinicalTrials.gov

What this trial studies

This clinical study aims to assess the function of the patellofemoral joint and the degree of arthritic degeneration following medial patellofemoral ligament (MPFL) reconstruction using fascia lata allograft. The study will follow a group of 25 patients over a minimum of 2, 5, and 10 years to evaluate both clinical outcomes and radiographic changes. The research addresses the multifactorial nature of patellofemoral disorders and aims to provide insights into the effectiveness of surgical interventions for this condition.

Who should consider this trial

Good fit: Ideal candidates for this study are adults diagnosed with MPFL injury confirmed by MRI, who are capable of providing informed consent and have no significant knee osteoarthritis.

Not a fit: Patients with local or systemic infections, significant knee osteoarthritis, or those who have had recent systemic corticosteroid therapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve surgical outcomes and rehabilitation strategies for patients with patellofemoral dislocation.

How similar studies have performed: Other studies have shown variable success rates for similar surgical interventions, indicating that while this approach has been tested, there is still room for improvement.

Eligibility criteria

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.
* 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).

Where this trial is running

Bologna

• IRCCS Istituto Ortopedico Rizzoli — Bologna, Italy (Recruiting)

Study contacts

• Principal investigator: Stefano Zaffagnini, MD, PhD — Istituto Ortopedico Rizzoli
• Study coordinator: Stefano Zaffagnini, MD

Conditions Patellofemoral Dislocation; MPFL reconstruction