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CompletedNCT01059721Updated Feb 8, 2012

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

An interventional study of Medialising insertion of patella tendon in Patella Dislocation, sponsored by Medical University of Graz. Completed. Open to participants aged 10 Years to 18 Years. Per ClinicalTrials.gov, last updated 2012-02-08.

Sponsored by Medical University of Graz · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
43
Allocation
Non-randomized
Ages
10 Years to 18 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Patella Dislocation

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Keywords

  • Centralisation
  • Patella dislocation
  • Open epiphyses
  • Malalignment syndrome
  • Relapse rate
03

In context

Patellar Dislocation

41 studies on the registry are indexed under Patellar Dislocation; 9 are open to participants now.

This study's enrollment of 43 is below the median of 50 across 22 interventional studies indexed under Patellar Dislocation.

Browse Patellar Dislocation studies →

Lead sponsor

Medical University of Graz is the lead sponsor of 471 studies on the registry; 98 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
10 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Operative procedure soft tissue realignment performed between 1999 and 2004

Exclusion criteria

Exclusion Criteria:

  • Syndromal patella dislocation
  • Genetic disorders
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
43 participants (actual)

Study arms

  • Experimental
    Soft tissue realignment

    group cohort label

    Procedure: Medialising insertion of patella tendon

Interventions

  • ProcedureMedialising insertion of patella tendon

    surgical treatment of medialising tibial tuberosity

06

What researchers measure

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

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 8, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01059721
Responsible party
Frank Schneider, MD (consultant orthopedic surgeon, Medical University of Graz) — Principal investigator
First posted
Feb 1, 2010
Start date
Jan 2010
Primary completion
Apr 2010
Completion
Jul 2010
Last update
Feb 8, 2012

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2012. You cannot join it, but the record below documents what was studied.

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