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

Sponsor

Medical University of Graz (Other)

Overall Status

Completed

CT.gov ID

NCT01059721

Collaborator

(none)

Enrollment

Arm

5.9

Duration (Months)

Study Details

Study Description

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	N/A

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 Design

Study Type:

Interventional

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 :

Jan 1, 2010

Actual Primary Completion Date :

Apr 1, 2010

Actual Study Completion Date :

Jul 1, 2010

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Soft tissue realignment

group cohort label

Procedure: Medialising insertion of patella tendon

surgical treatment of medialising tibial tuberosity

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Radiological investigation [6-10 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

10 Years to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Operative procedure soft tissue realignment performed between 1999 and 2004

Exclusion Criteria:

Syndromal patella dislocation
Genetic disorders

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Medical University of Graz

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Frank Schneider, MD, consultant orthopedic surgeon, Medical University of Graz

ClinicalTrials.gov Identifier:

NCT01059721

Other Study ID Numbers:

PatellaGraz

First Posted:

Feb 1, 2010

Last Update Posted:

Feb 8, 2012

Last Verified:

Feb 1, 2012

Keywords provided by Frank Schneider, MD, consultant orthopedic surgeon, Medical University of Graz

Centralisation

Patella dislocation

Open epiphyses

Malalignment syndrome

Relapse rate

Additional relevant MeSH terms:

Joint Dislocations

Patellar Dislocation

Study Results

No Results Posted as of Feb 8, 2012