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

Not Applicable

Completed

• Conditions: Patella Dislocation
• Interventions: Procedure: Medialising insertion of patella tendon

• Registration Number: NCT01059721
• Lead Sponsor: Medical University of Graz

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.

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2010-01-29
• Study First Submitted QC: 2010-01-29
• Study First Posted: 2010-02-01
• Primary Completion: 2010-04
• Study Completion: 2010-07
• Status Verified: 2012-02
• Last Update Submitted: 2012-02-07
• Last Update Posted: 2012-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

Inclusion Criteria

• Operative procedure soft tissue realignment performed between 1999 and 2004

Exclusion Criteria

• Syndromal patella dislocation
• Genetic disorders

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Soft tissue realignment	Medialising insertion of patella tendon	group cohort label

Primary Outcome Measures

Name	Time	Method
Lyshom Score, Tegner-activity scale, VAS Pain assessment.Own examination form especially for children	6 to 10 Years

Secondary Outcome Measures

Name	Time	Method
Radiological investigation	6-10 years