Clinical trial NCT03827980: Long- and Midterm Outcomes of Osteoarticular Infections in Paediatric Patients
Official title: LOOP- Long- and Midterm Outcomes of Osteoarticular Infections in Paediatric Patients.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Haematogenous Osteomyelitis
Septic Arthritis
Keywords: Acute Haematogenous Osteomyelitis
Septic Arthritis
Outcome
Osteoarticular Infections
Follow-up
Lead sponsor: University Children's Hospital Basel
Sponsor class: OTHER
Collaborators: name: Luzerner Kantonsspital
First posted: 2019-02-04
Enrollment: 78
Sex: ALL
Minimum age (years): 4
Maximum age (years): 32
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Former patients admitted to one of the participating centres for an acute osteoarticular infection.

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.

Eligibility 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

Primary outcomes:
measure: subjective sequelae score of previously affected body region: lower extremity
timeFrame: Day 1 (at single study visit)
measure: subjective sequelae score of previously affected body region: upper extremity
timeFrame: Day 1 (at single study visit)
measure: relevant restricted range of motion
timeFrame: Day 1 (at single study visit)
Secondary outcomes:
measure: asymmetric axis of leg or arm
timeFrame: Day 1 (at single study visit)
measure: limb length discrepancy of > 1cm
timeFrame: Day 1 (at single study visit)
measure: abnormal gait (only in case of previously affected lower limb)
timeFrame: Day 1 (at single study visit)
measure: z-score decline of body height since hospital discharge (only in case of previously affected lower limb)
timeFrame: variable, between 4 and 14 years, depending on time frame between date of discharge and today's study visit.
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University Children's Hospital Basel
state: Basel-Stadt
city: Lucerne
country: Switzerland
facility: Children's Hospital Lucerne
Study officials:
affiliation: University Children's Hospital Basel
name: Nora Manz, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Manz N, Krieg AH, Heininger U, Ritz N. Evaluation of the current use of imaging modalities and pathogen detection in children with acute osteomyelitis and septic arthritis. Eur J Pediatr. 2018 Jul;177(7):1071-1080. doi: 10.1007/s00431-018-3157-3. Epub 2018 May 4.
citation: Manz N, Krieg AH, Buettcher M, Ritz N, Heininger U. Long-Term Outcomes of Acute Osteoarticular Infections in Children. Front Pediatr. 2020 Nov 25;8:587740. doi: 10.3389/fped.2020.587740. eCollection 2020.