Long- and Midterm Outcomes of Osteoarticular Infections in Paediatric Patients

Septic Arthritis Clinical Trial

— LOOP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03827980
• Other study ID #: 2018-02393
• Status: Completed
• Start date: February 8, 2019
• Est. completion date: December 31, 2019

Study information

• Verified date: April 2020
• Source: University Children's Hospital Basel
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: December 31, 2019
• Est. primary completion date: July 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 32 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Haematogenous Osteomyelitis
• Arthritis
• Arthritis, Infectious
• Infection
• Osteomyelitis
• Septic Arthritis

Intervention

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

Locations

Country	Name	City	State
Switzerland	University Children's Hospital Basel	Basel	Basel-Stadt
Switzerland	Children's Hospital Lucerne	Lucerne

Sponsors (2)

Lead Sponsor	Collaborator
Prof. Dr. Ulrich Heininger	Luzerner Kantonsspital

Country where clinical trial is conducted

Switzerland, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	subjective sequelae score of previously affected body region: lower extremity	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)
Primary	subjective sequelae score of previously affected body region: upper extremity	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)
Primary	relevant restricted range of motion	restricted range of motion of > 20° of previously affected body part / joint compared to the other side	Day 1 (at single study visit)
Secondary	asymmetric axis of leg or arm	asymmetric leg or arm axis of previously affected lower or upper limb, respectively.	Day 1 (at single study visit)
Secondary	limb length discrepancy of > 1cm	asymmetric length of legs/arms of previously affected lower or upper limb, respectively.	Day 1 (at single study visit)
Secondary	abnormal gait (only in case of previously affected lower limb)	abnormal gait (e.g. limping) at examination	Day 1 (at single study visit)
Secondary	z-score decline of body height since hospital discharge (only in case of previously affected lower limb)	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.