Long- and Midterm Outcomes of Osteoarticular Infections in Paediatric Patients (LOOP)

April 17, 2020 updated by: Prof. Dr. Ulrich Heininger

LOOP- Long- and Midterm Outcomes of Osteoarticular Infections in Paediatric Patients.

Multi-centre clinical follow-up study on patients with a history of acute haematogenous osteomyelitis and/or septic arthritis. The aim is to describe the frequency of sequelae in these former patients with osteoarticular infections. Patients will be invited to participate in a single follow-up visit including a standardised interview and a clinical examination. The collected data will be analyzed together with data from the patient's hospital stay.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Clinical follow-up study on patients with a history of acute haematogenous osteomyelitis and/or septic arthritis and were admitted to one of the participating centres between 2005 and 2014.

Former patients will be invited to participate in a single-follow-up visit which comprises a standardised interview (pain, disabilities in daily life and regarding sports) and a standardized clinical examination of the previously affected body part. This includes assessment of range of motion in affected and adjacent joints and in case of previously affected lower extremity leg axis, gait and body height (percentile).

The data collected during the follow-up visit will be analyzed in a descriptive manner together with data of the patient's hospital stay including baseline data, laboratory works, microbiological results and both antibiotic and surgical treatment.

Study Type

Observational

Enrollment (Actual)

78

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
      • Lucerne, Switzerland, 6000
        • Children's hospital Lucerne
    • Basel-Stadt
      • Basel, Basel-Stadt, Switzerland, 4056
        • University Children's 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

Ages Eligible for Study

4 years to 32 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Former patients admitted to one of the participating centres for an acute osteoarticular infection.

Description

Inclusion Criteria:

  • Patients who were previously admitted to the participating centres between January 2005 and November 2014
  • Patients with an International Classification of Disease code (ICD-10) discharge code of acute osteomyelitis (M86.00-M86.99) and/or septic arthritis (M00.00-M00.99)

Exclusion Criteria:

  • onset of symptoms > 2 weeks before admission
  • history of penetrating wound or Prior surgery at affected limb
  • incorrect ICD-10 coding
  • chronic or severe underlying disease or Treatment at time of infection that possibly compromises the patient's immunologic Response (e.g. cancer, immunodeficiency, immunosuppressive therapy)
  • insufficient command of German language to understand patient Information and informed consent

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
subjective sequelae score of previously affected body region: lower extremity
Time Frame: Day 1 (at single study visit)

Assessment of current pain and ability to perform physical activities summarized in a Subjective Sequelae Score modified after the PODCI (Pediatric Outcomes Data Collection Instrument) questionnaire and score:

Lower Extremity: 11 Questions, Points 0-35, 0 = no disabilities, 1-11 = minor disability, 12-23 = moderate disability, 24-35 = severe disability Question 1: Current pain: (0-5 Points: never/less than once a month/once a month/once a week/more than once a week/daily) Questions 2-11 (0-3 Points never/less than once a month/once a month/once a week/more than once a week/daily) 2) Short distance running 3) Long distance running 4) Walking > 100m 5) Walking > 1000m 6) Climbing stairs 7) Walking uphill 8) Walking downhill 9) Participation in ball games/sports 10) Kneeling down 11) Sitting low (e.g. car, couch)
Day 1 (at single study visit)
subjective sequelae score of previously affected body region: upper extremity
Time Frame: Day 1 (at single study visit)

Assessment of current pain and ability to perform physical activities summarized in a Subjective Sequelae Score modified after the PODCI (Pediatric Outcomes Data Collection Instrument) questionnaire and score:

Upper Extremity: 6 Questions, Points 0-35, 0 = no disabilities, 1-6 = minor disability, 7-13 = moderate disability, 14-20 = severe disability Question 1: Current pain: (0-5 Points: never/less than once a month/once a month/once a week/more than once a week/daily) Questions 2-6 (0-3 Points never/less than once a month/once a month/once a week/more than once a week/daily) 2) Light work with upper body 3) Heavy work (e.g. Lifting heavy things) 4) Using Tools 5) Putting weight on upper body 6) Overhead work
Day 1 (at single study visit)
relevant restricted range of motion
Time Frame: Day 1 (at single study visit)
restricted range of motion of > 20° of previously affected body part / joint compared to the other side
Day 1 (at single study visit)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
asymmetric axis of leg or arm
Time Frame: Day 1 (at single study visit)
asymmetric leg or arm axis of previously affected lower or upper limb, respectively.
Day 1 (at single study visit)
limb length discrepancy of > 1cm
Time Frame: Day 1 (at single study visit)
asymmetric length of legs/arms of previously affected lower or upper limb, respectively.
Day 1 (at single study visit)
abnormal gait (only in case of previously affected lower limb)
Time Frame: Day 1 (at single study visit)
abnormal gait (e.g. limping) at examination
Day 1 (at single study visit)
z-score decline of body height since hospital discharge (only in case of previously affected lower limb)
Time Frame: variable, between 4 and 14 years, depending on time frame between date of discharge and today's study visit.
decline in body height between hospital discharge and study visit
variable, between 4 and 14 years, depending on time frame between date of discharge and today's study visit.

Collaborators and Investigators

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

Sponsor

Prof. Dr. Ulrich Heininger

Collaborators

Luzerner Kantonsspital

Investigators

  • Principal Investigator: Nora Manz, MD, University Children's 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)

February 8, 2019

Primary Completion (ACTUAL)

July 31, 2019

Study Completion (ACTUAL)

December 31, 2019

Study Registration Dates

First Submitted

January 24, 2019

First Submitted That Met QC Criteria

January 30, 2019

First Posted (ACTUAL)

February 4, 2019

Study Record Updates

Last Update Posted (ACTUAL)

April 20, 2020

Last Update Submitted That Met QC Criteria

April 17, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018-02393

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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