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Status unknownNCT04673188MPFLUpdated Dec 17, 2020

Predicting Factors for the Outcome of Surgical Treatment for Patellar Instability

An interventional study of Reconstruction of MPFL with or without tibial tuberositas osteotomy in Patellar Dislocation, sponsored by Nik Žlak. Status unknown at 1 site in Slovenia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-12-17.

Sponsored by Nik Žlak · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Dec 2020), so the status shown — last known as Enrolling by invitation — may be out of date.

From the registry’s dates

  • Registered 6 months after the study started (first participant enrolled Jun 2020, registered Dec 2020).
Phase
Not applicable
Study type
Interventional
Enrollment
145
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.
02

Conditions studied

  • Patellar Dislocation

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Keywords

  • Medial patello femoral ligament
  • Patellar instability
  • Reconstruction
  • Predicting factors
03

In context

Patellar Dislocation

41 studies on the registry are indexed under Patellar Dislocation; 9 are open to participants now.

This study's planned enrollment of 145 is above the median of 50 across 22 interventional studies indexed under Patellar Dislocation.

Browse Patellar Dislocation studies →

Lead sponsor

This is the only study on the registry with Nik Žlak as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
145 participants (estimated)

Interventions

  • ProcedureReconstruction 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 2-8 years

  2. 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.

    Time frame: 2-8 years

  3. 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.

    Time frame: 2-8 years

  4. 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.

    Time frame: 2-8 years

  5. 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.

    Time frame: 2-8 years

Secondary outcomes

  1. 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.

    Time frame: 2-8 years

07

Study locations

1 site
  • Department of Orthopaedic Surgery of the Ljubljana University Medical Centre
    Ljubljana, 1000, Slovenia
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 17, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04673188
Lead sponsor
Nik Žlak
Collaborators
University of Ljubljana, Faculty of Medicine, University of Ljubljana
Responsible party
Nik Žlak (Principal investigator, Doctor of medicine, PhD student, University Medical Centre Ljubljana) — Sponsor-investigator
First posted
Dec 17, 2020
Start date
Jun 1, 2020
Primary completion
Sep 2024 (estimated)
Completion
Sep 2024 (estimated)
Last update
Dec 17, 2020

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2020. You cannot join it, but the record below documents what was studied.

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