Predicting Factors for the Outcome of Surgical Treatment for Patellar Instability

NCT04673188 | Unknown

• 1 other identifier: KME 0120-169/2020/4
• Study Type: interventional
• Target: 145
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is:

1. 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. 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.

Conditions

Patellar Dislocation

Keywords

Medial patello femoral ligament; Patellar instability; Reconstruction; Predicting factors

Outcome Measures

Primary Outcomes (5)

• 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

• 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

• 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

• 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

• 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 Outcomes (1)

• Patellar position change

  2-8 years

Interventions

Reconstruction of MPFL with or without tibial tuberositas osteotomy PROCEDURE

Reconstruction of the medial patellofemoral ligament with autologous grafts with or without osteotomy and transfer of tibial tuberosities.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients over 18 years of age
• surgical intervention with MPFL reconstruction
• with or without tibial tuberosity transposition (TTT).

You may not qualify if:

• 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

Sponsors & Collaborators

• Nik Žlak: lead
• University of Ljubljana, Faculty of Medicine: collaborator
• University of Ljubljana: collaborator

Study Sites (1)

Department of Orthopaedic Surgery of the Ljubljana University Medical Centre

Ljubljana, 1000, Slovenia

Location

MeSH Terms

Conditions

Patellar Dislocation

Condition Hierarchy (Ancestors)

Joint Dislocations; Joint Diseases; Musculoskeletal Diseases; Wounds and Injuries; Knee Injuries; Leg Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal investigator, Doctor of medicine, PhD student

Model Details: Prospective cohort study

Study Record Dates

• First Submitted: December 1, 2020
• First Posted: December 17, 2020
• Study Start: June 1, 2020
• Primary Completion: September 1, 2024
• Study Completion: September 1, 2024
• Last Updated: December 17, 2020

Record last verified: 2020-12

Locations

SL (1)