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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Frank Schneider, MD, Medical University of Graz
ClinicalTrials.gov Identifier:
NCT01059721
First received: January 29, 2010
Last updated: February 7, 2012
Last verified: February 2012
  Purpose

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.


Condition Intervention
Patella Dislocation
Procedure: Medialising insertion of patella tendon

Study Type: Interventional
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 ]

Enrollment: 43
Study Start Date: January 2010
Study Completion Date: July 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Soft tissue realignment
group cohort label
Procedure: Medialising insertion of patella tendon
surgical treatment of medialising tibial tuberosity

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

Ages Eligible for Study:   10 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Operative procedure soft tissue realignment performed between 1999 and 2004

Exclusion Criteria:

  • Syndromal patella dislocation
  • Genetic disorders
  Contacts and Locations
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No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Frank Schneider, MD, consultant orthopedic surgeon, Medical University of Graz
ClinicalTrials.gov Identifier: NCT01059721     History of Changes
Other Study ID Numbers: PatellaGraz
Study First Received: January 29, 2010
Last Updated: February 7, 2012
Health Authority: Austria: Ethikkommission

Keywords provided by Medical University of Graz:
Centralisation
Patella dislocation
Open epiphyses
Malalignment syndrome
Relapse rate

Additional relevant MeSH terms:
Dislocations
Patellar Dislocation
Wounds and Injuries
Knee Injuries
Leg Injuries

ClinicalTrials.gov processed this record on September 18, 2014