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Orthopaedic Proceedings
Vol. 100-B, Issue SUPP_2 | Pages 29 - 29
1 Feb 2018
A CORE OUTCOME MEASUREMENT SET FOR LOW BACK PAIN CLINICAL TRIALS
Chiarotto A Boers M Deyo R Buchbinder R Corbin T Costa L Foster N Grotle M Koes B Kovacs F Lin C Maher C Pearson A Peul W Schoene M Turk D van Tulder M Terwee C Ostelo R
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Background & purpose

Measurement inconsistency across clinical trials is tackled by the development of a core outcome measurement set. Four core outcome domains were recommended for clinical trials in patients with non-specific LBP (nsLBP): physical functioning, pain intensity, health-related quality of life (HRQoL), and number of deaths. This study aimed to reach consensus on core instruments to measure the first three domains.

Methods & Results

The Steering Committee overseeing this project selected 17 potential core instruments for physical functioning, three for pain intensity, and five for HRQoL. Evidence on their measurement properties in nsLBP was synthesized in three systematic reviews using COSMIN methodology. Researchers, clinicians, and patients (n = 208) were invited in a Delphi survey to seek consensus on which instruments to endorse as core. Consensus was a-priori set at 67% of participants agreeing on endorsing an instrument. Two Delphi rounds were run (response rates = 44% and 41%). Agreement was reached on endorsing the Oswestry Disability Index (ODI 2.1a) for physical functioning, the Numeric Rating Scale (NRS) for pain intensity, but not on other instruments. Several participants demanded to have free of charge core instruments. Taking these results into account, the steering committee formulated the following recommendations: ODI 2.1a or 24-item Roland Morris Disability Questionnaire for physical functioning, NRS for pain intensity, Short-Form 12 or 10-item PROMIS Global Health for HRQoL.

Orthopaedic Proceedings
Vol. 92-B, Issue SUPP_I | Pages 78 - 78
1 Mar 2010
PAPER 45: EARLY DYNAMIZATION BY REDUCED FIXATION STIFFNESS DOES NOT IMPROVE FRACTURE HEALING IN A RAT FEMORAL OSTEOTOMY MODEL
Willie B Blakytny R Goeckelmann M Schoene M Ignatius A Claes L
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Introduction: Dynamization is used to improve the healing process. The optimal time for dynamization however remains unknown. In this study we proved the hypothesis that an early dynamization will improve the fracture healing.

Material and Methods: Twenty-four rats underwent a diaphyseal femoral osteotomy, with a 1mm gap. The osteotomy was stabilized by either rigid (R-group; n=8) or flexible (F-group; n=8) external fixation. The dynamized group (D-group: n=8) had a rigid fixation for 1 week, and then a flexible fixation for the remaining 4 weeks. The flexible fixation design resulted in an axial stiffness of 10N/mm and the rigid fixation in 74N/mm. After 5 weeks, healing was evaluated by biomechanical, densitometric, and histological methods.

Results: The flexural rigidity was 47% higher in the R-group than in the F-group (p< 0.01). Also, the flexural rigidity was 45% higher in the R-group than in the D-group (p< 0.01) (Table 1). Mineralized callus tissue volume was 37% lower in the R-group than the D-group (p=0.002).

Conclusion: The hypothesis could not be supported, in that early dynamization did not improve healing compared to rigid or flexible fixation. The rigid fixation had a stiffer callus with smaller callus volume, and more calcified tissue in the whole callus. The rigid fixation had bridging in the gap more often, which explains the increased flexural rigidity measured. Dynamization utilized in previous studies allowed closure of the fracture gap and thereby enhanced the rate of healing, which was not the case in the present investigation.