Trial Outcomes & Findings for Developing a COMputerised Bone Age Tool (NCT NCT02617901)

Last Updated: 2020-01-14

Results Overview

Bone age was assessed from DXA and conventional radiographs of the left hand and wrist based on the Greulich and Pyle and Tanner and Whitehouse methods of bone age assessment. Interclass correlation was calculated to determine observer agreement between radiographs and DXA

Recruitment status

COMPLETED

Study phase

Target enrollment

20 participants

Primary outcome timeframe

18 months

Results posted on

2020-01-14

Participant Flow

Participant milestones

Participant milestones
Measure	Recruited Children Children aged below 16 years attending the Radiology Department for a left hand radiograph in order to assess bone age on the basis of clinical need. There was one male and one female from each of five age groups (\< 5 years; 5 to 7 years; 8 to 10 years; 11 to 13 years; 14 to 16 years). Recruited children had intervention in the form of a left hand DXA which was anonymised and from which 2 observers independently assessed bone age according to Greulich and Pyle method on 2 separate occasions at least 4 weeks apart. Radiographs and DXA were read in random and varied order.
Overall Study STARTED	20
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Developing a COMputerised Bone Age Tool

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Recruited Children n=20 Participants Children aged below 16 years attending the Radiology Department for a left hand radiograph in order to assess bone age on the basis of clinical need. There was one male and one female from each of five age groups (\< 5 years; 5 to 7 years; 8 to 10 years; 11 to 13 years; 14 to 16 years). Recruited children had intervention in the form of a left hand DXA which was anonymised and from which the same 2 observers independently assessed bone age according to Greulich and Pyle method on 2 separate occasions at least 4 weeks apart. Radiographs and DXA were read in random and varied order.
Age, Customized Age, Customized · <5 years	4 Participants n=5 Participants
Age, Customized Age, Customized · 5 - 7 years	4 Participants n=5 Participants
Age, Customized Age, Customized · 8 to 10 years	4 Participants n=5 Participants
Age, Customized Age, Customized · 11 to 13 years	4 Participants n=5 Participants
Age, Customized Age, Customized · 14 to 16 years	4 Participants n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants
Region of Enrollment United Kingdom	20 Participants n=5 Participants

PRIMARY outcome

Timeframe: 18 months

Population: Children presenting to Endocrine Clinic

Outcome measures

Outcome measures
Measure	Recruited Children n=20 Participants Children aged below 16 years attending the Radiology Department for a left hand radiograph in order to assess bone age on the basis of clinical need. There will be one male and one female from each of five age groups (\< 5 years; 5 to 7 years; 8 to 10 years; 11 to 13 years; 14 to 16 years). All had left hand/wrist radiograph for bone age estimation
Number of Participants With Observer Agreement Between Bone Age as Assessed From Left Hand and Wrist DXA Compared to Radiographs	20 Participants

Adverse Events

Recruited Children

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Amaka C Offiah

Sheffield Children's NHS Foundation Trust

Phone: 0114 271 7557

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place