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Completed

NCT Number: NCT01059721

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

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.

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Key information

Age range

10 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Operative procedure soft tissue realignment performed between 1999 and 2004

Exclusion criteria

  • Syndromal patella dislocation
  • Genetic disorders

Treatment and study plan

Medialising insertion of patella tendon

Procedure

surgical treatment of medialising tibial tuberosity

Primary outcomes

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

    Time frame: 6 to 10 Years

Secondary outcomes

  1. Radiological investigation

    Time frame: 6-10 years

Sponsors and collaborators

Lead sponsor

Medical University of Graz

Other

Registry information

Official study title

Treatment of Patella Dislocation in Childhood and Adolescence. Soft Tissue Realignment of the Tibial Insertion of the Patella Tendon. Long-term Outcome.

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Feb 1, 2010
Registry last updated
Feb 8, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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