Outcome Assessment in Clinical Trials of Fracture-Healing

Morshed, Saam; Corrales, Luis; Genant, Harry K.; Miclau, Theodore

doi:10.2106/jbjs.g.01556

Cited by 146 publications

(97 citation statements)

References 31 publications

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“…Serial orthogonal radiographs taken at 6 weeks, 3 months, and 6 months after the fracture were reviewed by one observer (CEH) who was not a treating surgeon, to assess union by identifying bridging callus of at least two cortices [12,22,23]. Patient charts were reviewed for documentation of the ability to bear weight without pain.…”

Section: Methodsmentioning

confidence: 99%

2010 Mid-America Orthopaedic Association Physician in Training Award: Healing Complications Are Common After Locked Plating for Distal Femur Fractures

Henderson

Lujan²,

Kuhl

et al. 2011

Clinical Orthopaedics &Amp; Related Research

193

143

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Background Several mechanical studies suggest locking plate constructs may inhibit callus necessary for healing of distal femur fractures. However, the rate of nonunion and factors associated with nonunion are not well established. Questions/purposes We (1) determined the healing rate of distal femur fractures treated with locking plates, (2) assessed the effect of patient injury and treatment variables on fracture healing, and (3) compared callus formation in fractures that healed with those that did not heal. Patients and MethodsWe retrospectively reviewed 82 patients treated with 86 distal femur fractures using lateral locking plates. We reviewed all charts and radiographs to determine patient and treatment variables and then determined the effects of these variables on healing. We quantitatively measured callus at 6, 12, and 24 weeks.The minimum time for telephone interviews and SF-36v2 TM scores was 1 year (mean, 4.2 years; range, 1-7.2 years). Results Fourteen fractures (20%) failed to unite. Demographics and comorbidities were similar in patients who achieved healing compared with those who had nonunions. There were more empty holes in the plate adjacent to fractures that healed; comminuted fractures failed to heal more frequently than less comminuted fractures. Less callus formed in fractures with nonunions and in patients treated with stainless steel plates compared with titanium plates. Complications occurred in 28 of 70 fractures (40%), 19 of which had additional surgery. Conclusions We found a high rate of nonunion in distal femur fractures treated with locking plates. Nonunion presented late without hardware failure and with limited callus formation suggesting callus inhibition rather than hardware failure is the primary problem. Mechanical factors may play a role in the high rate of nonunion. Level of Evidence Level III, therapeutic study. See Guidelines for Authors for a complete description of levels of evidence.

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Section: Methodsmentioning

confidence: 99%

2010 Mid-America Orthopaedic Association Physician in Training Award: Healing Complications Are Common After Locked Plating for Distal Femur Fractures

Henderson

Lujan²,

Kuhl

et al. 2011

Clinical Orthopaedics &Amp; Related Research

193

143

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“…The clinical parameters evaluated at the last followup were: (1) absence of pain or tenderness on palpation, (2) absence of pain when strength gripping, and (3) full range of motion at the adjacent joint. The three radiographic key parameters for the evaluation were: (1) bridging of the fracture site by bone, callus, or trabeculae; (2) bridging of the fracture seen at three cortices; and (3) obliteration of the fracture line or cortical continuity [15]. Each of the four observers independently evaluated each of the monthly radiographs to determine time of healing.…”

Section: Methodsmentioning

confidence: 99%

Aseptic Forearm Nonunions Treated by Plate and Opposite Fibular Autograft Strut

Faldini

Pagkrati

Nanni

et al. 2009

Clinical Orthopaedics &Amp; Related Research

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Forearm nonunion frequently changes the relationship between the radius and ulna and may lead to impairment of forearm function. We propose a new surgical technique for aseptic forearm nonunions combining a fibular cortical autograft strut with a metal plate and a fibular intercalary autograft in cases with a segmental bone defect. We retrospectively reviewed 20 patients with a mean age of 31 years (range, 17-48 years) at the time of surgery. Minimum followup was 12 years (mean, 14 years; range, 12-21 years). There were no intraoperative or postoperative complications. At last followup, all forearm bones had remodeled. The mean visual analog pain scale was 1 (range, 0-3). Forearm function improved; there were no radiographic signs of ankle arthritis at followup. Surgical treatment of aseptic forearm nonunions by combining a massive fibular cortical autograft strut with a plate and associating a fibular intercalary autograft in case of a segmental bone defect led to bone healing, improved forearm function, and a durable outcome with long-term followup.

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“…1,2 Although measures have been developed for hip and ankle fractures, 3 there is no validated measure that adequately describes functional healing for tibial fractures. 1 A recently published systematic review that evaluated variability in the assessment of fracture healing in orthopedic trauma studies reported that the 3 most commonly used clinical criteria were the absence of pain or tenderness on palpation or examination, the absence of pain or tenderness when bearing weight and the ability to bear weight.…”

mentioning

confidence: 99%

“…4 Similarly, another review evaluating the clinical criteria used to define fracture union found that the 4 most common criteria were the absence of pain or tenderness when bearing weight, the absence of pain or tenderness on palpitation or examination, the ability to bear weight and the ability to walk or perform activities of daily living with no pain. 2 Pain at the fracture site is commonly regarded as a sign that a fracture has not yet healed.…”

mentioning

confidence: 99%

“…2 Consequently, pain alone may be an inadequate measure to determine if a fracture has healed. The ability to bear weight on injured appendages has been suggested to serve as an objective measure for healing of tibial fractures treated by external fixation 5 because weight-bearing ability has been shown previously to increase with time postfracture 6,7 and has been found to correlate well with bone stiffness.…”

mentioning

confidence: 99%

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Development and preliminary validation of a Function IndeX for Trauma (FIX-IT)

et al. 2013

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Background: Assessing fracture healing in clinical trials is subjective. The new Function IndeX for Trauma (FIX-IT) score provides a simple, standardized approach to assess weight-bearing and pain in patients with lower extremity fractures. We conducted an initial validation of the FIX-IT score. Methods:We conducted a cross-sectional study involving 50 patients with lower extremity fractures across different stages of healing to evaluate the reliability and preliminary validity of the FIX-IT score. Patients were independently examined by 2 orthopedic surgeons, 1 orthopedic fellow, 2 orthopedic residents and 2 research coordinators. Patients also completed the Short Form-36 version 2 (SF-36v2) questionnaire, and convergent validity was tested with the SF-36v2.Results: For interrater reliability, the intraclass correlation coefficents ranged from 0.637 to 0.915. The overall interrater reliability for the total FIX-IT score was 0.879 (95% confidence interval 0.828-0.921). The correlations between the FIX-IT score and the SF-36 ranged from 0.682 to 0.770 for the physical component summary score, from 0.681 to 0.758 for the physical function subscale, and from 0.677 to 0.786 for the role-physical subscale. Conclusion:The FIX-IT score had high interrater agreement across multiple examiners. Moreover, FIX-IT scores correlate with the physical scores of the SF-36. Although additional research is needed to fully validate FIX-IT, our results suggest the potential for FIX-IT to be a reliable adjunctive clinician measure to evaluate healing in lower extremity fractures. Level of evidence: Diagnostic Study Level I.Contexte : Évaluer la guérison d'une fracture dans le cadre d'essais cliniques est un processus subjectif. Le nouveau score FIX-IT (pour Function IndeX for Trauma) constitue une approche simple et standardisée pour évaluer la mise en charge et la douleur chez les patients ayant subi une fracture d'un membre inférieur. Nous avons procédé à une validation initiale du score FIX-IT.Méthodes : Nous avons réalisé une étude transversale regroupant 50 patients qui ont subi une fracture d'un membre inférieur, à différents stades de la guérison, pour éva -luer la fiabilité et la validité préliminaire du score FIX-IT. Les patients ont été examinés indépendamment par 2 chirurgiens orthopédistes, 1 chargé de cours en orthopédie, 2 médecins résidents en orthopédie et 2 coordonnateurs de recherche. Les patients ont aussi répondu au questionnaire SF-36v2 (Short Form-36 version 2) et la validité convergente a été vérifiée au moyen du SF-36v2.

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Outcome Assessment in Clinical Trials of Fracture-Healing

Cited by 146 publications

References 31 publications

2010 Mid-America Orthopaedic Association Physician in Training Award: Healing Complications Are Common After Locked Plating for Distal Femur Fractures

2010 Mid-America Orthopaedic Association Physician in Training Award: Healing Complications Are Common After Locked Plating for Distal Femur Fractures

Aseptic Forearm Nonunions Treated by Plate and Opposite Fibular Autograft Strut

Development and preliminary validation of a Function IndeX for Trauma (FIX-IT)

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