Clinical trial NCT01059721: 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
Overall status: COMPLETED
Phase: NA
Conditions: Patella Dislocation
Keywords: Centralisation
Patella dislocation
Open epiphyses
Malalignment syndrome
Relapse rate
Lead sponsor: Medical University of Graz
Sponsor class: OTHER
First posted: 2010-02-01
Enrollment: 43
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* Operative procedure soft tissue realignment performed between 1999 and 2004

Exclusion Criteria:

* Syndromal patella dislocation
* Genetic disorders

Primary outcomes:
measure: Lyshom Score, Tegner-activity scale, VAS Pain assessment.Own examination form especially for children
timeFrame: 6 to 10 Years
Secondary outcomes:
measure: Radiological investigation
timeFrame: 6-10 years
Other outcomes:
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