Clinical and Functional Outcome After Lateral Trochlear Lengthening Osteotomy Lateral Trochlear Lengthening Osteotomy (Tro_Le_Tomy)

November 9, 2020 updated by: University Hospital, Basel, Switzerland

Tro_Le_Tomy - Clinical and Functional Outcome After Lateral Trochlear Lengthening Osteotomy

The purpose of this study is to evaluate the functional and clinical outcome of this new lengthening osteotomy of the lateral trochlea in patients with patella instability, trochlear dysplasia Dejour type A or B, short lateral articular trochlea quantified by the lateral condyle index and presence of a lateral trochlear bump.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

A short lateral articular trochlea leads to failure in stabilizing the patella close to full Extension of the knee. To address this type of pathology, a trochlear lengthening osteotomy was described. To date only case reports describing the clinical outcome of this new osteotomy exist and information on functional outcome regarding muscle strength and electromyography (EMG) data is lacking. The purpose of this study is to evaluate the functional and clinical outcome of this new lengthening osteotomy of the lateral trochlea in patients with patella instability, trochlear dysplasia Dejour type A or B, short lateral articular trochlea quantified by the lateral condyle index and presence of a lateral trochlear bump.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
6

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Basel, Switzerland, 4031
        • Orthopädie/Traumatologie, University Hospital Basel

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients treated between 01/2014 and 09/2017 (n=6) with lateral trochlear lengthening osteotomy at the Clinic of Orthopaedics and Traumatology at the University Hospital Basel

Description

Inclusion Criteria:

  • 2 years (as of September 2019) since conducting a lateral trochlear lengthening osteotomy

Exclusion Criteria:

  • Inability to provide informed consent
  • Neurological disorders potentially affecting lower extremity muscle strength.
  • Surgery involving the patellofemoral joint prior to the lateral trochlear lengthening osteotomy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
presence of a recurrent patellar dislocation/ radiological reduction of the trochlear bump postoperative by plain radiograph of the knee/ lateral view
Time Frame: at Baseline

presence of a recurrent patellar dislocation postoperative by plain radiograph of the knee/ lateral view:

  • crossing sign: The sign is positive when the trochlear groove lies in same plane as anterior border of lateral condyle. It represents a flattened trochlear groove
  • double contour sign: The sign is positive when the anterior border of lateral condyle lies anterior to anterior border of medial condyle. It represents a convex trochlear groove/hypoplastic medial condyle
  • presence of a lateral trochlear bump prominence
  • the patellar height will be evaluated according to Insall-Salvati method (normal between 0.8 and 1.2) and Caton Deschamps method (normal between 0.6 and 1.3)
at Baseline
presence of a recurrent patellar dislocation/ radiological reduction of the trochlear bump postoperative by Skyline patellar view
Time Frame: at Baseline
The trochlea form will be assessed, the existence of trochlear dysplasia will be confirmed and classified according to Dejour
at Baseline
(Change in) Lateral condyle index assessed by MRI of the knee
Time Frame: at Baseline
Lateral condyle index assessed by MRI of the knee (preoperative (always conducted) and in the cases where they are available postoperative MRIs). The lateral condyle index was designed to measure the lateral trochlea by comparing the anterior cartilaginous trochlea (a) and the posterior aspect (p) [(a:p)× 100].
at Baseline

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Subjective Evaluation of the outcome of the operation
Time Frame: at Baseline

The patients will be asked to subjectively evaluate the outcome of the operation according to the following options:

  • Excellent: Patient is fully recovered and has resumed all activity without restrictions
  • Somewhat Improved: Patient is mostly recovered and has resumed a majority of activities
  • Unchanged: Patient outcome is equivalent to pre-operative complaints
  • Somewhat Worse: Patient is experiencing symptoms worse than pre-operative complaints
  • Significantly Worse: Patient outcome is worse than pre-operative complaints with significantly worse symptoms
at Baseline
Kujala Anterior Knee Pain Scale (AKPS)
Time Frame: at Baseline
The Kujala AKPS is a 13-item screening instrument designed to assess patellofemoral pain in adolescents and young adults, with a variable ordinal response format. For example, a 'Limp' score would be scored as follows: none (5), slight/periodic (3), constant (0). Total scores range from 0 to 100.
at Baseline
Lysholm Knee Score
Time Frame: at Baseline
The Lysholm Knee Score consists of eight items that measure: pain (25 points), instability (25 points), locking (15 points), swelling (10 points), limp (5 points), stair climbing (10 points), squatting (5 points), and need for support (5 points). Every question response has been assigned an arbitrary score on an increasing scale. The total score is the sum of each response to the eight questions, and may range from 0-100. Higher scores indicate a better outcome with fewer symptoms or disability.
at Baseline
Visual analog scale score (VAS)
Time Frame: at Baseline
The visual analogue scale (VAS) is a 100-mm horizontal line on which the patient's pain intensity is represented by a point between the extremes of "no pain at all" and "worst pain imaginable.
at Baseline
Tegner activity scale
Time Frame: at Baseline
The Tegner activity scale is a one-item score that graded activity based on work and sports activities on a scale of 0 to 10. Zero represents disability because of knee problems and 10 represents national or international level soccer.
at Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Basel, Switzerland

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: +41 (0)61 32 87133 Muendermann, Prof., Orthopädie/Traumatologie, University Hospital Basel

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 29, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 4, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 7, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 10, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 9, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2019-01405; ch20Muendermann2

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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