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Prospective randomized feasibility trial to assess the use of rhPDGF-BB in treatment of distal radius fractures
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Surgical Sciences, Orthopaedics.
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Surgical Sciences, Orthopaedics.
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Surgical Sciences, Orthopaedics.
2015 (English)In: Journal of Orthopaedic Surgery and Research, ISSN 1749-799X, E-ISSN 1749-799X, Vol. 10, 37Article in journal (Refereed) Published
Abstract [en]

BACKGROUND: Recombinant human platelet-derived growth factor BB (rhPDGF-BB) combined with an osteoconductive scaffold (β-TCP) has been demonstrated to increase bone formation, but rhPDGF-BB has not been studied in human fractures. The purpose of this study was to evaluate the safety and potential use of locally administered rhPDGF-BB/β-TCP (Augment®) in acute wrist fractures.

METHODS: Forty patients with unstable distal radial fracture were randomized to closed reduction and external fixation alone (n = 20) or combined with injection of rhPDGF-BB/β-TCP (Augment®) into the fracture (n = 20). All patients were followed for 24 weeks. Outcome was based on adverse events, fracture displacement on radiographs, fracture healing, range of motion, grip strength, pain, and the disability of the arm, shoulder and hand (DASH) score.

RESULTS: There were no serious adverse events in the study, but the pin tract infection rate was significantly lower in the Augment® group. There was no difference between the groups in fracture healing time, based on number of healed cortices or fracture displacement. The Augment® group had an early temporary significant decrease in wrist flexion, but no difference in range of motion at 24 weeks. There were no differences between the two treatment groups for any other outcome variables.

CONCLUSION: rhPDGF-BB/β-TCP (Augment®) is safe and convenient for local administration into wrist fractures. In this pilot study, we could not detect any reduced healing time in the Augment® group although potential efficacy should be addressed in larger studies.

CLINICAL TRIAL REGISTRATION NUMBER: The clinical trial registration number for the study protocol is BMPI-2014-02-E.

Place, publisher, year, edition, pages
2015. Vol. 10, 37
Keyword [en]
Distal radius fracture; External fixation; PDGF; Calcium phosphate; Radiographic evaluation; Clinical evaluation; Prospective; Randomized
National Category
Orthopedics
Identifiers
URN: urn:nbn:se:uu:diva-266609DOI: 10.1186/s13018-015-0174-zISI: 000369737900001PubMedID: 25888774OAI: oai:DiVA.org:uu-266609DiVA: diva2:868348
Available from: 2015-11-10 Created: 2015-11-10 Last updated: 2017-12-01Bibliographically approved
In thesis
1. Fractures of the distal radius: Factors related to radiographic evaluation, conservative treatment and fracture healing
Open this publication in new window or tab >>Fractures of the distal radius: Factors related to radiographic evaluation, conservative treatment and fracture healing
2017 (English)Doctoral thesis, comprehensive summary (Other academic)
Abstract [en]

Distal radius fractures (DRFs) are one of the most common injuries encountered in orthopaedic practise. Such fractures are most often treated conservatively, but surgical treatment has become increasingly common. This trend is not entirely scientifically based

The aims of this thesis were threefold: to increase measurement precision in dorsal angulation (DA) on radiographs and computer tomographies (CTs); to assess the results after shortened plaster cast fixation time in reduced DRFs; and to evaluate the feasibility and safety of applying Augment® (rhPDGF-BB/β-TCP) in DRFs.

In Paper I and Appendix 1 and 2, a semi-automatic CT-based three-dimensional method was developed to measure change in DA over time in DRFs. This approach proved to be a better (more sensitive) method than radiography in determining changes in DA in fractures of the distal radius.

In Paper II, a CT model was used to simulate lateral radiographic views of different radial directions in relation to the X-ray. Using an alternative reference point on the distal radius, precision and accuracy in measuring DA was increased.

Paper III and IV are based on a prospective and randomised clinical study (the GitRa trial) that compares clinical and radiographic outcomes after plaster cast removal at 10 days versus 1 month in 109 reduced DRFs. Three patients in the early mobilised group were excluded because of fracture dislocation (n=2) or a feeling of fracture instability (n=1). For the remaining patients in the early mobilised group (51/54) a limited but temporary gain in range of motion, but a slight increase in radiographic displacement were observed. Our results suggest that plaster cast removal at 10 days after reduction of DRFs is not feasible.

Paper V is based on a prospective, randomised clinical study (the GEM trial) in which 40 externally fixated DRFs were randomised to rhPDGF-BB/β-TCP into the fracture gap or to the control group. Augment® proved to be convenient and safe during follow-up (24 weeks). However, because of the nature of the study design, the effect on fracture healing could not be determined. A decrease in pin infections was seen in the Augment® group, a finding we could not explain.

Place, publisher, year, edition, pages
Uppsala: Acta Universitatis Upsaliensis, 2017. 124 p.
Series
Digital Comprehensive Summaries of Uppsala Dissertations from the Faculty of Medicine, ISSN 1651-6206 ; 1290
National Category
Orthopedics
Identifiers
urn:nbn:se:uu:diva-312931 (URN)978-91-554-9796-5 (ISBN)
Public defence
2017-03-03, Rosénsalen, Ing 95/96, Akademiska Sjukhuset, Uppsala, 09:00 (Swedish)
Opponent
Supervisors
Available from: 2017-02-09 Created: 2017-01-15 Last updated: 2017-02-15

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Christersson, AlbertSandén, BengtLarsson, Sune

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