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Trial registered on ANZCTR


Registration number
ACTRN12621000625875
Ethics application status
Approved
Date submitted
22/02/2021
Date registered
24/05/2021
Date last updated
24/05/2021
Date data sharing statement initially provided
24/05/2021
Date results information initially provided
24/05/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
In those undertaking Periacetabular Osteotomy (PAO), does the use of i-Factor bone graft affect bone healing?
Scientific title
A retrospective case series of patients undergoing Periacetabular Osteotomy (PAO) for hip dysplasia: does the use of i-Factor bone graft affect bone healing?
Secondary ID [1] 301877 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Developmental Dysplasia of the Hip (DDH) 318371 0
Periacetabular Osteotomy of the Hip (PAO) 318372 0
Condition category
Condition code
Musculoskeletal 316390 316390 0 0
Other muscular and skeletal disorders
Surgery 319142 319142 0 0
Surgical techniques

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Periacetabular Osteotomy (PAO) is a common hip preserving surgery often performed on patients with hip dysplasia. During a PAO operation the surgeon makes a series of cuts to the bone to reposition the acetabulum in the pelvis, in order to restore a more normal hip joint anatomy. Screws are then placed in the bones to stabilize this position. The surgery ranges between two to four hours. During the healing process, new bone forms across the cut surfaces to secure the repositioned acetabulum in the pelvis, establishing proper alignment of the hip joint ball and socket.

All patients will have undergone PAO by an experienced single orthopaedic surgeon. The intervention group have also received i-Factor which is a bone morphogenetic protein designed to enhance bone healing process. The product used was 12mm in length, 25mm in width and 4mm in thickness. This is applied directly to the bony cuts during surgery and does not significantly change the duration of surgery. Patients usually remain in hospital for 4-5 days post-operatively, and walk with crutches to reduced the weightbearing on the hip for 6 weeks following the surgery.

All data will be collected retrospectively from all patients fulfilling the inclusion criteria from the dates 01/01/2009 to 31/03/2020
Intervention code [1] 318164 0
Diagnosis / Prognosis
Comparator / control treatment
The control group have received the same surgical procedure, performed by the same experienced orthopaedic surgeon. The control group has not received the i-Factor product during their surgery. They undergo the same hospital admission and weightbearing restriction following surgery.
Control group
Active

Outcomes
Primary outcome [1] 325714 0
Degree of bone healing (assessed by X-ray) will be assessed as a composite outcome:

This will be graded as either:
1. Poor union, or
2. Partial or Good union
Timepoint [1] 325714 0
6 weeks post-surgery
Secondary outcome [1] 388890 0
Complications will be assessed as a composite secondary outcome. For example: infections, intraoperative fractures or heterotopic ossification.
Timepoint [1] 388890 0
- During surgery (taken from surgical notes)
- 6 week surgical follow-up appointment

Eligibility
Key inclusion criteria
Patients who have undergone periacetabular osteotomy with a single surgeon.
Minimum age
15 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(i) Tönnis Osteoarthritis score > 1
(ii) concurrent femoral osteotomy
(iii) other diagnosed significant hip condition (e.g. trauma, rheumatoid arthritis, avascular necrosis, perthes disease, slipped upper femoral epiphysis, osteochondritis dissecans, fracture, septic arthritis, bursitis or tendinitis)
(iv) neurological, other musculoskeletal or rheumatological diseases affecting hip function

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis
Primary Outcome:
- Dichotomous (non-union vs partial/full union)
- Independent variable = intervention (i-Factor: Yes / No)
- Covariates: Age and Sex
- Logistic Regression with Generalised Estimating Equation (GEE) to account for paired limbs. Results will be presented as odds ratio's with 95% Confidence Intervals (CI)

Secondary Outcome: Complications will be descriptively reported

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 306295 0
Commercial sector/Industry
Name [1] 306295 0
Cerapedics Inc.
Address [1] 306295 0
11025 Dover Street, Suite 1600
Westminster, CO 80021
USA
Country [1] 306295 0
United States of America
Primary sponsor type
University
Name
La Trobe Sport and Exercise Medicine Research Centre, La Trobe University
Address
La Trobe Sport and Exercise Medicine Research Centre
Plenty Rd & Kingsbury Dr
School of Allied Health, Human Services and Sport
College of Science, Health and Engineering
La Trobe University
Victoria 3086
Country
Australia
Secondary sponsor category [1] 306788 0
None
Name [1] 306788 0
Address [1] 306788 0
Country [1] 306788 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306511 0
La Trobe University Human Research Ethics Committee
Ethics committee address [1] 306511 0
Plenty Rd & Kingsbury Dr,
Bundoora
VIC 3086
Australia
Ethics committee country [1] 306511 0
Australia
Date submitted for ethics approval [1] 306511 0
Approval date [1] 306511 0
22/06/2020
Ethics approval number [1] 306511 0
HEC20201

Summary
Brief summary
This project is a retrospective case-series of patients who have undergone periacetabular osteotomy with a single orthopaedic surgeon. All surgical patients performed at one institution received i-Factor during their surgery, surgical patients performed at other institution received standard care. The use of i-Factor was standard clinical practice for Mr Balakumar at the time of its use. The primary aim of this project is to compare bone healing timeframes between this two groups of patients. The secondary aim of this project is to compare surgical complications (for example infection rates) between these two groups. Medical notes and standard post-operative X-Rays will be reviewed.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 104114 0
Dr Joanne Kemp
Address 104114 0
Health Sciences Building 3 Room 512
La Trobe Sport and Exercise Medicine Research Centre
School of Allied Health, Human Services and Sport
College of Science, Health and Engineering
La Trobe University
Plenty Rd & Kingsbury Dr
Bundoora
VIC 3086
Country 104114 0
Australia
Phone 104114 0
+61 3 9479 1428
Fax 104114 0
Email 104114 0
j.kemp@latrobe.edu.au
Contact person for public queries
Name 104115 0
Dr Joanne Kemp
Address 104115 0
Health Sciences Building 3 Room 512
La Trobe Sport and Exercise Medicine Research Centre
School of Allied Health, Human Services and Sport
College of Science, Health and Engineering
La Trobe University
Plenty Rd & Kingsbury Dr
Bundoora
VIC 3086
Country 104115 0
Australia
Phone 104115 0
+61 3 9479 1428
Fax 104115 0
Email 104115 0
j.kemp@latrobe.edu.au
Contact person for scientific queries
Name 104116 0
Dr Joanne Kemp
Address 104116 0
Health Sciences Building 3 Room 512
La Trobe Sport and Exercise Medicine Research Centre
School of Allied Health, Human Services and Sport
College of Science, Health and Engineering
La Trobe University
Plenty Rd & Kingsbury Dr
Bundoora
VIC 3086
Country 104116 0
Australia
Phone 104116 0
+61 3 9479 1428
Fax 104116 0
Email 104116 0
j.kemp@latrobe.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
As this is a retrospective study, patients did not provide consent for data to be made publicly available.
What supporting documents are/will be available?
No other documents available
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
No
Results – basic reporting
Results – plain English summary