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

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ClinicalTrials.gov Identifier: NCT03827980
Recruitment Status : Active, not recruiting
First Posted : February 4, 2019
Last Update Posted : June 28, 2019
Sponsor:
Collaborator:
Luzerner Kantonsspital
Information provided by (Responsible Party):
Prof. Dr. Ulrich Heininger, University Children's Hospital Basel

Brief Summary:
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.

Condition or disease Intervention/treatment
Acute Haematogenous Osteomyelitis Septic Arthritis Other: no intervention, only clinical examination

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.


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Study Type : Observational
Actual Enrollment : 78 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: LOOP- Long- and Midterm Outcomes of Osteoarticular Infections in Paediatric Patients.
Actual Study Start Date : February 8, 2019
Estimated Primary Completion Date : July 31, 2019
Estimated Study Completion Date : July 31, 2019

Resource links provided by the National Library of Medicine



Intervention Details:
  • Other: no intervention, only clinical examination
    standardised interview and clinical examination


Primary Outcome Measures :
  1. 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)


  2. 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


  3. 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


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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

  4. 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



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Ages Eligible for Study:   4 Years to 32 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Former patients admitted to one of the participating centres for an acute osteoarticular infection.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03827980


Locations
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Switzerland
University Children's Hospital Basel
Basel, Basel-Stadt, Switzerland, 4056
Children's Hospital Lucerne
Lucerne, Switzerland, 6000
Sponsors and Collaborators
Prof. Dr. Ulrich Heininger
Luzerner Kantonsspital
Investigators
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Principal Investigator: Nora Manz, MD University Children's Hospital Basel

Publications:
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Responsible Party: Prof. Dr. Ulrich Heininger, Chair, Infectious Diseases/Vaccinology, University Children's Hospital Basel
ClinicalTrials.gov Identifier: NCT03827980     History of Changes
Other Study ID Numbers: 2018-02393
First Posted: February 4, 2019    Key Record Dates
Last Update Posted: June 28, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Prof. Dr. Ulrich Heininger, University Children's Hospital Basel:
Acute Haematogenous Osteomyelitis
Septic Arthritis
Outcome
Osteoarticular Infections
Follow-up
Additional relevant MeSH terms:
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Infection
Osteomyelitis
Arthritis, Infectious
Arthritis
Joint Diseases
Musculoskeletal Diseases
Bone Diseases, Infectious
Bone Diseases