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Outcome After Soft Tissue Realignment of the Tibial Insertion of the Patella Tendon

Primary Purpose

Patella Dislocation

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Medialising insertion of patella tendon
Sponsored by
Medical University of Graz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Patella Dislocation focused on measuring Centralisation, Patella dislocation, Open epiphyses, Malalignment syndrome, Relapse rate

Eligibility Criteria

10 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Operative procedure soft tissue realignment performed between 1999 and 2004

Exclusion Criteria:

  • Syndromal patella dislocation
  • Genetic disorders

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Soft tissue realignment

    Arm Description

    group cohort label

    Outcomes

    Primary Outcome Measures

    Lyshom Score, Tegner-activity scale, VAS Pain assessment.Own examination form especially for children

    Secondary Outcome Measures

    Radiological investigation

    Full Information

    First Posted
    January 29, 2010
    Last Updated
    February 7, 2012
    Sponsor
    Medical University of Graz
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01059721
    Brief Title
    Outcome After Soft Tissue Realignment of the Tibial Insertion of the Patella Tendon
    Official Title
    Treatment of Patella Dislocation in Childhood and Adolescence. Soft Tissue Realignment of the Tibial Insertion of the Patella Tendon. Long-term Outcome.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2012
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2010 (undefined)
    Primary Completion Date
    April 2010 (Actual)
    Study Completion Date
    July 2010 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Medical University of Graz

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Soft tissue realignment of the tibial insertion of the patella tendon is a simple operative technique for treating dislocation of the patella in childhood and adolescence. It is performed in children with either recurrent dislocation or complicated primary dislocation in cases with malalignment or maltracking of the patella and a lateralised tibial tuberosity. It can be performed in patients with open epiphyses. We investigate long-term outcome after this procedure.
    Detailed Description
    Method. Investigation of the outcome of a relatively new method for centralisation of the insertion of the patella tendon in patients with open epiphyses. Using a soft tissue technique the patella tendon is released from the tibial tuberosity with the tendon still fixed to the distal periosteum. The tibial periosteum is split on the lateral border of the tibia distally. Together with lateral release this procedure releases the patella tendon which finds a new insertion more medially. Because the tendon is still fixed at the distal periosteum no additional fixation is needed and therefore no complications occur at the tibial apophysis due to osteosynthetic material. Full weight bearing is possible after 4 weeks and movement is not restricted.Results. From 1999 to 2004 a total of about 90 operations in about 80 patients for soft tissue centralisation of the distal insertion of the patella tendon were carried out on children and adolescents aged between 10 and 18 years old. This study is a retrospective analysis of the outcome after 6 to 10 years. Relevant outcome criteria will be evaluated with the occurrence of recurring dislocation, the Lysholm score, the Tegner activity scale and subjective measurement with the VAS scale and an additional functional outcome score, that we created especially for children. Eventual occurrence of growth disturbance or osteoarthritis will be documented be clinical or radiological features.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Patella Dislocation
    Keywords
    Centralisation, Patella dislocation, Open epiphyses, Malalignment syndrome, Relapse rate

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    43 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Soft tissue realignment
    Arm Type
    Experimental
    Arm Description
    group cohort label
    Intervention Type
    Procedure
    Intervention Name(s)
    Medialising insertion of patella tendon
    Intervention Description
    surgical treatment of medialising tibial tuberosity
    Primary Outcome Measure Information:
    Title
    Lyshom Score, Tegner-activity scale, VAS Pain assessment.Own examination form especially for children
    Time Frame
    6 to 10 Years
    Secondary Outcome Measure Information:
    Title
    Radiological investigation
    Time Frame
    6-10 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    10 Years
    Maximum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Operative procedure soft tissue realignment performed between 1999 and 2004 Exclusion Criteria: Syndromal patella dislocation Genetic disorders

    12. IPD Sharing Statement

    Learn more about this trial

    Outcome After Soft Tissue Realignment of the Tibial Insertion of the Patella Tendon

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