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NCT Number: NCT03827980

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.

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Key information

Conditions

Acute Haematogenous Osteomyelitis Arthritis Arthritis, Infectious Infections Joint Diseases Musculoskeletal Diseases Septic Arthritis

Age range

4 year–32 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Children's Hospital Basel, Basel, Canton of Basel-City, Switzerland

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

no intervention, only clinical examination

Other

standardised interview and clinical examination

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Prof. Dr. Ulrich Heininger

Other

Collaborators

  • Luzerner Kantonsspital

Registry information

Official study title

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

Acronym: LOOP

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Feb 4, 2019
Registry last updated
Apr 20, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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