Acute Haematogenous OsteomyelitisLOOPNCT03827980
Long- and Midterm Outcomes of Osteoarticular Infections in Paediatric Patients
An observational study of Acute Haematogenous Osteomyelitis and Septic Arthritis, run by Prof. Dr. Ulrich Heininger at 2 sites in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 4 to 32 years
- Conditions the study is for
- Acute Haematogenous Osteomyelitis, Septic Arthritis
- How many people
- 78 participants
- Where
- 2 sitesSwitzerland
- Study dates
- 8 Feb 2019to 31 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 32 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Former patients admitted to one of the participating centres for an acute osteoarticular infection.
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Switzerland2 sites
University Children's Hospital Basel
Basel, Canton of Basel-City, 4056
Children's Hospital Lucerne
Lucerne, 6000
About this study
Official title: LOOP- 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.
Read the 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.
- Being tested
- no intervention, only clinical examination
- Keywords
- Acute Haematogenous Osteomyelitis, Septic Arthritis, Outcome, Osteoarticular Infections, Follow-up
- Medical subject headings
- Arthritis, Infectious
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no intervention, only clinical examinationOther
standardised interview and clinical examination
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Day 1 (at single study visit)
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
Measured: Day 1 (at single study visit)
relevant restricted range of motion
restricted range of motion of > 20° of previously affected body part / joint compared to the other side
Measured: Day 1 (at single study visit)
Secondary outcomes (4)
asymmetric axis of leg or arm
asymmetric leg or arm axis of previously affected lower or upper limb, respectively.
Measured: Day 1 (at single study visit)
limb length discrepancy of > 1cm
asymmetric length of legs/arms of previously affected lower or upper limb, respectively.
Measured: Day 1 (at single study visit)
abnormal gait (only in case of previously affected lower limb)
abnormal gait (e.g. limping) at examination
Measured: Day 1 (at single study visit)
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
Measured: variable, between 4 and 14 years, depending on time frame between date of discharge and today's study visit.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2019
- Study start8 Feb 2019
- Primary completion31 Jul 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute Haematogenous OsteomyelitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prof. Dr. Ulrich Heininger
- Sponsor type
- University, hospital or other
- Collaborators
- Luzerner Kantonsspital
- Responsible party
- Sponsor-investigator, Prof. Dr. Ulrich Heininger, University Children's Hospital Basel
- Investigators
- Nora Manz, MD, Principal investigator, University Children's Hospital Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03827980
- Sponsor's protocol ID
- 2018-02393
- Other IDs
- 2018
- Acronym
- LOOP
- Status last verified
- Apr 2020
- First submitted
- 24 Jan 2019
- Last updated
- 20 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 29728840Manz 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.
PubMed 33335875
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LOOP- Long- and Midterm Outcomes of Osteoarticular Infections in Paediatric Patients.
- ClinicalTrials.gov ID
- NCT03827980
- Acronym / sponsor ID
- LOOP / 2018-02393
- Keywords
- Acute Haematogenous Osteomyelitis, Septic Arthritis, Outcome, Osteoarticular Infections, Follow-up
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Prof. Dr. Ulrich HeiningerUniversity, hospital or other
- Collaborators
- Luzerner Kantonsspital
- Study start
- 8 Feb 2019 (actual)
- Primary completion
- 31 Jul 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 4 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 4 to 32 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Former patients admitted to one of the participating centres for an acute osteoarticular infection.
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| no intervention, only clinical examinationstandardised interview and clinical examination | Other | – |
Primary outcome
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)
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
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
4 secondary outcomes
asymmetric axis of leg or arm
Time frame: Day 1 (at single study visit)
limb length discrepancy of > 1cm
Time frame: Day 1 (at single study visit)
abnormal gait (only in case of previously affected lower limb)
Time frame: Day 1 (at single study visit)
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2020.
- Background: PubMed 29728840Manz 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.
- Derived from this study: PubMed 33335875Manz 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.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nora Manz, MD principal investigator
University Children's Hospital Basel
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Haematogenous Osteomyelitis and Septic Arthritis, run by Prof. Dr. Ulrich Heininger at 2 sites in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
subjective sequelae score of previously affected body region: lower extremity (time frame: Day 1 (at single study visit)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03827980, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2020.