Predicting Factors for the Outcome of Surgical Treatment for Patellar Instability
- Conditions
- Patellar Dislocation
- Registration Number
- NCT04673188
- Lead Sponsor
- Nik Žlak
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 145
- patients over 18 years of age
- surgical intervention with MPFL reconstruction
- with or without tibial tuberosity transposition (TTT).
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Change of subjective knee status evaluated with EQ-5D 2-8 years 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.
Change of subjective knee status evaluated with KOOS 2-8 years 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.
Change of subjective knee status on Tegner activity scale 2-8 years 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.
Change of subjective knee status evaluated with Kujala score 2-8 years 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.
Change of subjective knee status on IKDC 2-8 years 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.
- Secondary Outcome Measures
Name Time Method Patellar position change 2-8 years 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.
Trial Locations
- Locations (1)
Department of Orthopaedic Surgery of the Ljubljana University Medical Centre
🇸🇮Ljubljana, Slovenia