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
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
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
NCT ID
NCT01059721
First Posted
January 29, 2010
Last Updated
February 7, 2012
Sponsor
Medical University of Graz
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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