Predicting Factors for the Outcome of Surgical Treatment for Patellar Instability

Patellar Dislocation Clinical Trial

— MPFL  

Official title:

Predicting Factors for the Outcome of Surgical Treatment for Patellar Instability

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04673188
• Other study ID #: KME 0120-169/2020/4
• Status: Enrolling by invitation
• Phase: N/A
• Start date: June 1, 2020
• Est. completion date: September 2024

Study information

• Verified date: December 2020
• Source: University Medical Centre Ljubljana
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is:

1. to analyze the success of operative stabilization of the patellar joint with the reconstruction of the medial patellofemoral ligament (MPFL) in terms of the subjective status of the knee, the general quality of life, and physical activity

2. to study the influence of specific preoperative (demographic and anamnestic data of the patient, radiological parameters of the knee joint) and intra-operative factors (place of femoral insertion of MPFL graft, patella height, degree of damage to the cartilaginous surfaces of the knee joint) on the subjective outcome of surgical treatment.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 145
• Est. completion date: September 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• patients over 18 years of age

• surgical intervention with MPFL reconstruction

• with or without tibial tuberosity transposition (TTT).

Exclusion Criteria:

• trochleoplasty,

• corrective knee osteotomy

• reparative cartilage treatment

• reconstruction of other knee ligaments

• meniscus repair

• movement impairments

• plegia

• paresis

• neuromuscular diseases

• participation rejection

• rejection to complete the control questionnaires

• lack of understanding of the Slovenian language

Related Conditions & MeSH terms

• Patellar Dislocation

Intervention

Procedure:
• Reconstruction of MPFL with or without tibial tuberositas osteotomy
Reconstruction of the medial patellofemoral ligament with autologous grafts with or without osteotomy and transfer of tibial tuberosities.

Locations

Country	Name	City	State
Slovenia	Department of Orthopaedic Surgery of the Ljubljana University Medical Centre	Ljubljana

Sponsors (3)

Lead Sponsor	Collaborator
Nik Žlak	University of Ljubljana, Faculty of Health Sciences Ljubljana, University of Ljubljana, Faculty of Medicine

Country where clinical trial is conducted

Slovenia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of subjective knee status evaluated with EQ-5D	It is expected that the subjective status of the knee will significantly improve after surgical stabilisation of the patellar joint. The change in subjective knee status will be measured with EQ-5D (European quality of life in 5 dimensions; min 0, max 100). Higher scores on the questioner mean a better outcome.	2-8 years
Primary	Change of subjective knee status evaluated with KOOS	It is expected that the subjective status of the knee will significantly improve after surgical stabilisation of the patellar joint. The change in subjective knee status will be measured with KOOS (Knee osteoarthritis outcome score; min 0, max 100). Higher scores on the questioner mean a better outcome.	2-8 years
Primary	Change of subjective knee status on Tegner activity scale	It is expected that the subjective status of the knee will significantly improve after surgical stabilisation of the patellar joint. The change in subjective knee status will be measured with Tegner activity scale (min 0, max 10). Higher scores on the scale mean a better outcome.	2-8 years
Primary	Change of subjective knee status evaluated with Kujala score	It is expected that the subjective status of the knee will significantly improve after surgical stabilisation of the patellar joint. The change in subjective knee status will be measured with Kujala questioner (min 0, max100). Higher score means a better outcome.	2-8 years
Primary	Change of subjective knee status on IKDC	It is expected that the subjective status of the knee will significantly improve after surgical stabilisation of the patellar joint. The change in subjective knee status will be assessed with IKDC (International knee documentation committeemin; 0, max 100) questioner. Higher score on the questioner means a better outcome.	2-8 years
Secondary	Patellar position change	The height of the patella in the late post-operative period is not expected to differ from its position immediately after the procedure. The patellar height will be assessed with Caton-Deschamp index on standard lateral X-rays before surgery, immediately after surgery and at least six months after surgery. Reference values for normal patellar height are 0.8 - 1.2.	2-8 years