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In those undertaking Periacetabular Osteotomy (PAO), does the use of i-Factor bone graft affect bone healing?

A retrospective case series of patients undergoing Periacetabular Osteotomy (PAO) for hip dysplasia: does the use of i-Factor bone graft affect bone healing?

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12621000625875
Enrollment
295
Registered
2021-05-24
Start date
2020-06-22
Completion date
2021-03-29
Last updated
2021-06-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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 t

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

Sponsors

La Trobe Sport and Exercise Medicine Research Centre, La Trobe University
Lead SponsorUniversity

Study design

Allocation
Non-randomised trial
Primary purpose
Treatment

Eligibility

Sex/Gender
All
Age
15 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Patients who have undergone periacetabular osteotomy with a single surgeon.

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

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026