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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01059721
Recruitment Status : Completed
First Posted : February 1, 2010
Last Update Posted : February 8, 2012
Information provided by (Responsible Party):
Frank Schneider, MD, 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.

Condition or disease Intervention/treatment Phase
Patella Dislocation Procedure: Medialising insertion of patella tendon Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 43 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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.
Study Start Date : January 2010
Actual Primary Completion Date : April 2010
Actual Study Completion Date : July 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dislocations

Arm Intervention/treatment
Experimental: Soft tissue realignment
group cohort label
Procedure: Medialising insertion of patella tendon
surgical treatment of medialising tibial tuberosity

Primary Outcome Measures :
  1. Lyshom Score, Tegner-activity scale, VAS Pain assessment.Own examination form especially for children [ Time Frame: 6 to 10 Years ]

Secondary Outcome Measures :
  1. Radiological investigation [ Time Frame: 6-10 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Operative procedure soft tissue realignment performed between 1999 and 2004

Exclusion Criteria:

  • Syndromal patella dislocation
  • Genetic disorders

Responsible Party: Frank Schneider, MD, consultant orthopedic surgeon, Medical University of Graz Identifier: NCT01059721     History of Changes
Other Study ID Numbers: PatellaGraz
First Posted: February 1, 2010    Key Record Dates
Last Update Posted: February 8, 2012
Last Verified: February 2012

Keywords provided by Frank Schneider, MD, Medical University of Graz:
Patella dislocation
Open epiphyses
Malalignment syndrome
Relapse rate

Additional relevant MeSH terms:
Joint Dislocations
Patellar Dislocation
Bone Diseases
Musculoskeletal Diseases
Wounds and Injuries
Knee Injuries
Leg Injuries