Long- and Midterm Outcomes of Osteoarticular Infections in Paediatric Patients

Completed

• Conditions: Acute Haematogenous Osteomyelitis; Septic Arthritis

• Registration Number: NCT03827980
• Lead Sponsor: Prof. Dr. Ulrich Heininger

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.

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 Timeline

• Study First Submitted: 2019-01-24
• Study First Submitted QC: 2019-01-30
• Study First Posted: 2019-02-04
• Study Start: 2019-02-08
• Primary Completion: 2019-07-31
• Study Completion: 2019-12-31
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-17
• Last Update Posted: 2020-04-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 78

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
subjective sequelae score of previously affected body region: lower extremity	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)
relevant restricted range of motion	Day 1 (at single study visit)	restricted range of motion of \> 20° of previously affected body part / joint compared to the other side
subjective sequelae score of previously affected body region: upper extremity	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

Secondary Outcome Measures

Name	Time	Method
abnormal gait (only in case of previously affected lower limb)	Day 1 (at single study visit)	abnormal gait (e.g. limping) at examination
z-score decline of body height since hospital discharge (only in case of previously affected lower limb)	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
limb length discrepancy of > 1cm	Day 1 (at single study visit)	asymmetric length of legs/arms of previously affected lower or upper limb, respectively.
asymmetric axis of leg or arm	Day 1 (at single study visit)	asymmetric leg or arm axis of previously affected lower or upper limb, respectively.

Trial Locations

Locations (2)

Children's Hospital Lucerne; 🇨🇭 Lucerne, Switzerland

University Children's Hospital Basel; 🇨🇭 Basel, Basel-Stadt, Switzerland