Outcome After Soft Tissue Realignment of the Tibial Insertion of the Patella Tendon
This study has been completed.
Medical University of Graz
Information provided by (Responsible Party):
Frank Schneider, MD, Medical University of Graz
First received: January 29, 2010
Last updated: February 7, 2012
Last verified: February 2012
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Treatment of Patella Dislocation in Childhood and Adolescence. Soft Tissue Realignment of the Tibial Insertion of the Patella Tendon. Long-term Outcome.|
Resource links provided by NLM:
Further study details as provided by Medical University of Graz:
Primary Outcome Measures:
- Lyshom Score, Tegner-activity scale, VAS Pain assessment.Own examination form especially for children [ Time Frame: 6 to 10 Years ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Radiological investigation [ Time Frame: 6-10 years ] [ Designated as safety issue: Yes ]
|Study Start Date:||January 2010|
|Study Completion Date:||July 2010|
|Primary Completion Date:||April 2010 (Final data collection date for primary outcome measure)|
Experimental: Soft tissue realignment
group cohort label
Procedure: Medialising insertion of patella tendon
surgical treatment of medialising tibial tuberosity
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.
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