NCT01059721

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
43

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2010

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

January 29, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 1, 2010

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2010

Completed
Last Updated

February 8, 2012

Status Verified

February 1, 2012

Enrollment Period

3 months

First QC Date

January 29, 2010

Last Update Submit

February 7, 2012

Conditions

Patella Dislocation

Keywords

CentralisationPatella dislocationOpen epiphysesMalalignment syndromeRelapse rate

Outcome Measures

Primary Outcomes (1)

  • Lyshom Score, Tegner-activity scale, VAS Pain assessment.Own examination form especially for children

    6 to 10 Years

Secondary Outcomes (1)

  • Radiological investigation

    6-10 years

Study Arms (1)

Soft tissue realignment

EXPERIMENTAL

group cohort label

Procedure: Medialising insertion of patella tendon

Interventions

Medialising insertion of patella tendonPROCEDURE

surgical treatment of medialising tibial tuberosity

Soft tissue realignment

Eligibility Criteria

Age10 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Operative procedure soft tissue realignment performed between 1999 and 2004

You may not qualify if:

  • Syndromal patella dislocation
  • Genetic disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Patellar Dislocation

Condition Hierarchy (Ancestors)

Joint DislocationsJoint DiseasesMusculoskeletal DiseasesWounds and InjuriesKnee InjuriesLeg Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
consultant orthopedic surgeon

Study Record Dates

First Submitted

January 29, 2010

First Posted

February 1, 2010

Study Start

January 1, 2010

Primary Completion

April 1, 2010

Study Completion

July 1, 2010

Last Updated

February 8, 2012

Record last verified: 2012-02