Patella DislocationNCT01059721
Outcome After Soft Tissue Realignment of the Tibial Insertion of the Patella Tendon
A study testing Medialising insertion of patella tendon in people with Patella Dislocation, run by Medical University of Graz.
Trial 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… Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Patella Dislocation
- What is being tested?
- Medialising insertion of patella tendon
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- No sites listed yet
- Study dates
- Jan 2010to Jul 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Operative procedure soft tissue realignment performed between 1999 and 2004
Who cannot join
- Syndromal patella dislocation
- Genetic disorders
About this study
Official title: Treatment of Patella Dislocation in Childhood and Adolescence. Soft Tissue Realignment of the Tibial Insertion of the Patella Tendon. Long-term Outcome.
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.
- Conditions
- Patella Dislocation
- Being tested
- Medialising insertion of patella tendon
- Keywords
- Centralisation, Patella dislocation, Open epiphyses, Malalignment syndrome, Relapse rate
- Medical subject headings
- Patellar Dislocation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medialising insertion of patella tendonProcedure or surgery
surgical treatment of medialising tibial tuberosity
| Study group | Role | What they receive |
|---|---|---|
| Soft tissue realignment | Experimental | group cohort label Receives: Procedure: Medialising insertion of patella tendon |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lyshom Score, Tegner-activity scale, VAS Pain assessment.Own examination form especially for children
Measured: 6 to 10 Years
Secondary outcomes (1)
Radiological investigation
Measured: 6-10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2010 (estimated)
- Study startJan 2010
- Primary completionApr 2010
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patella DislocationStudies of the same condition, open and under way.
- More trials run by Medical University of GrazThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Frank Schneider, MD, Medical University of Graz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01059721
- Sponsor's protocol ID
- PatellaGraz
- Status last verified
- Feb 2012
- First submitted
- 29 Jan 2010
- Last updated
- 8 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Patella Dislocation in Childhood and Adolescence. Soft Tissue Realignment of the Tibial Insertion of the Patella Tendon. Long-term Outcome.
- ClinicalTrials.gov ID
- NCT01059721
- Acronym / sponsor ID
- PatellaGraz
- Conditions
- Patella Dislocation
- Keywords
- Centralisation, Patella dislocation, Open epiphyses, Malalignment syndrome, Relapse rate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Apr 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 1 Feb 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Soft tissue realignment | Experimental | Procedure: Medialising insertion of patella tendongroup cohort label |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Operative procedure soft tissue realignment performed between 1999 and 2004
Key exclusion criteria (2 listed)
- Syndromal patella dislocation
- Genetic disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medialising insertion of patella tendonsurgical treatment of medialising tibial tuberosity | Procedure or surgery | Soft tissue realignment |
Primary outcome
Lyshom Score, Tegner-activity scale, VAS Pain assessment.Own examination form especially for children
Time frame: 6 to 10 Years
1 secondary outcome
Radiological investigation
Time frame: 6-10 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Medialising insertion of patella tendon in people with Patella Dislocation, run by Medical University of Graz.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lyshom Score, Tegner-activity scale, VAS Pain assessment.Own examination form especially for children (time frame: 6 to 10 Years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2012.