RESUMO
BACKGROUND: The decision to undergo breast reconstruction (BR) surgery after mastectomy is made during stressful circumstances. Many women do not feel well prepared to make this decision. OBJECTIVE: Using the Ottawa Decision Support Framework, this study aims to describe women's reasons to choose or not choose BR, BR knowledge, decisional preparedness, and decisional conflict about BR. Possible demographic, medical, BR knowledge, and attitudinal correlates of decisional conflict about BR were also evaluated. METHODS: Participants were 55 women with early-stage breast cancer drawn from the baseline data of a pilot randomized trial evaluating the efficacy of a BR decision support aid for breast cancer patients considering BR. RESULTS: The most highly ranked reasons to choose BR were the desire for breasts to be equal in size, the desire to wake up from surgery with a breast in place, and perceived bother of a scar with no breast. The most highly ranked reasons not to choose BR were related to the surgical risks and complications. Regression analyses indicated that decisional conflict was associated with higher number of reasons not to choose BR and lower levels of decisional preparedness. CONCLUSIONS: The results suggest that breast cancer patients considering BR may benefit from decisional support. IMPLICATIONS FOR CLINICAL PRACTICE: Healthcare professionals may facilitate decision making by focusing on reasons for each patient's uncertainty and unaddressed concerns. All patients, even those who have consulted with a plastic surgeon and remain uncertain about their decision, may benefit from decision support from a health professional.
Assuntos
Atitude Frente a Saúde , Neoplasias da Mama/cirurgia , Conflito Psicológico , Tomada de Decisões , Mamoplastia/psicologia , Adulto , Técnicas de Apoio para a Decisão , Feminino , Humanos , Pessoa de Meia-Idade , Projetos PilotoRESUMO
BACKGROUND: Osteocutaneous free flaps have become the primary reconstructive modality for segmental mandibulectomy defects. The advent of preoperative virtual surgical planning with stereolithic models and cutting templates has led to significant refinements in operative technique. In this article, the authors examine the value of computed tomography-guided preoperative virtual surgical planning on operative outcomes and efficiency after mandibular reconstruction with osteocutaneous free flaps. METHODS: A retrospective review was performed of all patients undergoing free flap mandible reconstruction at a single cancer center from 2002 to 2013. Surgical technique and operative time were assessed, as were overall complications and outcomes. Postoperative computed tomographic scans were also examined to determine the accuracy of osteotomies with and without virtual surgical planning. RESULTS: Ninety-two patients underwent osteocutaneous free flap reconstruction of the mandible during the study period. In 43 patients, the shaping of the neomandible was performed based on the prefabricated stereolithic models. The remaining 49 patients underwent preoperative computed tomographic imaging to design patient-specific cutting guides for the native mandible and the osteocutaneous flap. The use of preoperative computed tomography-guided planning resulted in less burring, fewer osteotomy revisions, and less bone grafting. Virtual surgical planning also significantly decreased operative time (666 minutes versus 545 minutes; p < 0.005). Review of postoperative computed tomographic scans demonstrated decreased rates of bony nonunion with virtual surgical planning, and there were no significant differences in overall outcomes or complications between the groups. CONCLUSIONS: Preoperative virtual surgical planning has refined mandible reconstruction with osteocutaneous free flaps through the introduction of patient-specific models, prebent plates, and osteotomy guides. Virtual surgical planning decreases operative time and improves the accuracy of free flap mandibular reconstruction. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, III.
Assuntos
Retalhos de Tecido Biológico , Reconstrução Mandibular/métodos , Cuidados Pré-Operatórios/métodos , Cirurgia Assistida por Computador , Tomografia Computadorizada por Raios X , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Humanos , Pessoa de Meia-Idade , Planejamento de Assistência ao Paciente , Estudos Retrospectivos , Fatores de Tempo , Resultado do Tratamento , Adulto JovemRESUMO
OBJECTIVE: The study aim was to test the acceptability and preliminary efficacy of a novel interactive web-based breast reconstruction decision support aid (BRAID) for newly diagnosed breast cancer patients considering mastectomy. METHODS: Fifty-five women considering mastectomy were randomly assigned to receive the BRAID versus the Cancer Support Community's Frankly Speaking About Cancer: Breast Reconstruction pamphlet. Participants completed measures of breast reconstruction (BR) knowledge, preparation to make a decision, decisional conflict, anxiety, and BR intentions before randomization and 2 weeks later. RESULTS: In terms of acceptability, enrollment into the study was satisfactory, but the rate of return for follow-up surveys was lower among BRAID participants than pamphlet participants. Both interventions were evaluated favorably in terms of their value in facilitating the BR decision, and the majority of participants completing the follow-up reported viewing the materials. In terms of preliminary efficacy, both interventions resulted in significant increases in BR knowledge and completeness and satisfaction with preparation to make a BR decision, and both interventions resulted in a significant reduction in decision conflict. However, there were no differences between interventions. CONCLUSION: A widely available free pamphlet and a web-based customized decision aid were highly utilized. The pamphlet was as effective in educating women about BR and prepared women equally as well to make the BR decision as compared with a more costly, customized web-based decision support aid. Copyright © 2015 John Wiley & Sons, Ltd.
Assuntos
Neoplasias da Mama/psicologia , Neoplasias da Mama/cirurgia , Técnicas de Apoio para a Decisão , Internet , Mamoplastia/psicologia , Aceitação pelo Paciente de Cuidados de Saúde/psicologia , Apoio Social , Adulto , Idoso , Feminino , Humanos , Mastectomia/psicologia , Pessoa de Meia-Idade , Projetos Piloto , Resultado do TratamentoRESUMO
The free fibula flap is the preferred reconstructive method for oncologic defects of the mandible. Arterial inflow of the extremity is routinely evaluated with several modalities; however, venous screening is rarely performed. Patients with cancer are at elevated risk of occult deep venous thrombosis (DVT). An asymptomatic thrombus encountered during free fibula reconstruction is a serious concern. Although such cases have been reported, we suspect the incidence of DVT during fibula free flap harvest is underappreciated. This monograph uses a case example to review risk factors for occult DVT, present a strategy for preoperative assessment, and provide a reconstructive algorithm to for mandibular reconstruction in such instances.
Assuntos
Fíbula/irrigação sanguínea , Retalhos de Tecido Biológico/irrigação sanguínea , Complicações Intraoperatórias/diagnóstico , Reconstrução Mandibular/métodos , Trombose Venosa/diagnóstico , Idoso , Doenças Assintomáticas , Feminino , Fíbula/transplante , Retalhos de Tecido Biológico/transplante , Humanos , Trombose Venosa/etiologiaRESUMO
IMPORTANCE: Time to surgery (TTS) is of concern to patients and clinicians, but controversy surrounds its effect on breast cancer survival. There remains little national data evaluating the association. OBJECTIVE: To investigate the relationship between the time from diagnosis to breast cancer surgery and survival, using separate analyses of 2 of the largest cancer databases in the United States. DESIGN, SETTING, AND PARTICIPANTS: Two independent population-based studies were conducted of prospectively collected national data from the Surveillance, Epidemiology, and End Results (SEER)-Medicare-linked database and the National Cancer Database (NCDB). The SEER-Medicare cohort included Medicare patients older than 65 years, and the NCDB cohort included patients cared for at Commission on Cancer-accredited facilities throughout the United States. Each analysis assessed overall survival as a function of time between diagnosis and surgery by evaluating 5 intervals (≤30, 31-60, 61-90, 91-120, and 121-180 days) and disease-specific survival at 60-day intervals. All patients were diagnosed with noninflammatory, nonmetastatic, invasive breast cancer and underwent surgery as initial treatment. MAIN OUTCOMES AND MEASURES: Overall and disease-specific survival as a function of time between diagnosis and surgery, after adjusting for patient, demographic, and tumor-related factors. RESULTS: The SEER-Medicare cohort had 94 544 patients 66 years or older diagnosed between 1992 and 2009. With each interval of delay increase, overall survival was lower overall (hazard ratio [HR], 1.09; 95% CI, 1.06-1.13; P < .001), and in patients with stage I (HR, 1.13; 95% CI, 1.08-1.18; P < .001) and stage II disease (HR 1.06; 95% CI, 1.01-1.11; P = .01). Breast cancer-specific mortality increased with each 60-day interval (subdistribution hazard ratio [sHR], 1.26; 95% CI, 1.02-1.54; P = .03). The NCDB study evaluated 115 790 patients 18 years or older diagnosed between 2003 and 2005. The overall mortality HR was 1.10 (95% CI, 1.07-1.13; P < .001) for each increasing interval, significant in stages I (HR, 1.16; 95% CI, 1.12-1.21; P < .001) and II (HR, 1.09; 95% CI, 1.05-1.13; P < .001) only, after adjusting for demographic, tumor, and treatment factors. CONCLUSIONS AND RELEVANCE: Greater TTS is associated with lower overall and disease-specific survival, and a shortened delay is associated with benefits comparable to some standard therapies. Although time is required for preoperative evaluation and consideration of options such as reconstruction, efforts to reduce TTS should be pursued when possible to enhance survival.
Assuntos
Neoplasias da Mama/mortalidade , Neoplasias da Mama/cirurgia , Idoso , Neoplasias da Mama/diagnóstico , Neoplasias da Mama Masculina/diagnóstico , Neoplasias da Mama Masculina/mortalidade , Neoplasias da Mama Masculina/cirurgia , Estudos de Coortes , Feminino , Humanos , Masculino , Medicare , Programa de SEER , Análise de Sobrevida , Fatores de Tempo , Estados Unidos/epidemiologiaRESUMO
BACKGROUND: Free fibula osteocutaneous flaps are the primary option for reconstruction after segmental mandibulectomies. This study evaluates the impact of CT-guided preoperative planning on operative outcomes after free fibula mandible reconstruction. METHODS: We conducted a retrospective review of all patients undergoing free fibula reconstruction of the mandible from 2002 to 2011. RESULTS: Fifty-seven patients underwent free fibula osteocutaneous flap reconstruction for head and neck cancers involving the mandible. Twelve patients had shaping of the neomandible performed on the back table while 20 patients underwent shaping in situ without the use of any adjunctive technology. The remaining 25 patients underwent preoperative CT imaging, which significantly decreased operative time (707 minutes vs 534 minutes; p < .0003) as well as overall costs ($24,532.50 vs $20,950.48). There were no significant differences in outcomes or complications. CONCLUSION: Preoperative, patient-specific CT modeling, and cutting guide fabrication outweigh the costs associated with the additional technology without jeopardizing overall outcomes or increasing complication rates.
Assuntos
Retalhos de Tecido Biológico/transplante , Neoplasias Mandibulares/diagnóstico por imagem , Neoplasias Mandibulares/cirurgia , Reconstrução Mandibular/métodos , Cirurgia Assistida por Computador/métodos , Tomografia Computadorizada por Raios X/métodos , Adulto , Idoso , Idoso de 80 Anos ou mais , Transplante Ósseo/métodos , Estudos de Coortes , Feminino , Fíbula/cirurgia , Seguimentos , Retalhos de Tecido Biológico/irrigação sanguínea , Rejeição de Enxerto , Sobrevivência de Enxerto , Neoplasias de Cabeça e Pescoço/patologia , Neoplasias de Cabeça e Pescoço/cirurgia , Humanos , Masculino , Neoplasias Mandibulares/patologia , Pessoa de Meia-Idade , Cuidados Pré-Operatórios/métodos , Estudos Retrospectivos , Resultado do Tratamento , Adulto JovemRESUMO
BACKGROUND: Free tissue transfer from an abdominal donor site has become a popular method for postmastectomy breast reconstruction. The detrimental effects of adjuvant chemotherapy on healing and the resulting clinical impact on patient outcome remains somewhat unclear for abdominal bulges and hernias resulting after free tissue transfer from the abdominal donor site. METHODS: An institutional review board-approved retrospective review of 155 free muscle-sparing transverse rectus abdominis myocutaneous (MS-TRAM) flaps performed for breast reconstruction was undertaken to evaluate the effect of adjuvant chemotherapy on abdominal donor-site morbidity. The primary outcome studied was the development of hernias and bulges. Statistical analysis was performed using univariate and multivariate classification and regression tree (CART) analysis. RESULTS: Of the 155 patients, 51 underwent bilateral MS-TRAM flaps and 104 underwent unilateral MS-TRAM flap reconstruction. Thirty-nine patients underwent adjuvant chemotherapy. A statistically significant association was seen between chemotherapy treatment and the incidence of hernias alone (P < 0.05; odds ratio, 6.42; 95% confidence interval, 0.88-73.58). Multivariable CART analyses corroborated these findings and revealed that presence of diabetes mellitus (DM), bilaterality, and receiving chemotherapy treatment were related to increased incidence of hernias (P = 0.011, 0.005, and 0.017, respectively) after controlling for clinical variables such as smoking status, chronic obstructive pulmonary disease, and type of closure. Univariate analyses also revealed a statistically significant association between bilaterality in conjunction with chemotherapy treatment and the incidence of hernias alone (P = 0.0002; odds ratio, 37.56; 95% confidence interval, 4.56-476.35). This highly significant finding is further augmented by multivariable CART analyses, which found that patients who were bilateral and underwent chemotherapy treatment or those with DM were significantly more likely to develop hernias (P < 0.001 and P = 0.016, respectively). CONCLUSIONS: To date, our study is the single largest series of abdominal donor-site complications in patients receiving chemotherapy and free MS-TRAM breast reconstruction. We have demonstrated an increase in the incidence of abdominal donor-site complications, specifically abdominal bulges and hernias, in patients undergoing chemotherapy for advanced stages of breast cancer. This increased complication rate is most pronounced in patients requiring chemotherapy who undergo bilateral reconstruction, and is also a significant risk for patients receiving chemotherapy who have preexisting DM.
Assuntos
Parede Abdominal , Neoplasias da Mama/tratamento farmacológico , Neoplasias da Mama/cirurgia , Mamoplastia , Retalho Miocutâneo , Sítio Doador de Transplante , Adulto , Antineoplásicos , Quimioterapia Adjuvante , Feminino , Hérnia Abdominal , Humanos , Microcirurgia , Análise Multivariada , Retalho Miocutâneo/efeitos adversos , Estudos Retrospectivos , Fatores de RiscoRESUMO
The radial forearm free flap has gained popularity in head and neck reconstruction after oncologic resection because of its versatility. This popularity has only intensified with the advances in technique and instrumentation. Although debated in the past, the success of using the deep venae comitantes system for flap drainage is well documented. Although the use of couplers in a variety of flap anastomoses has been described in the literature, to our knowledge this is the first series presented on the use of couplers in small, deep system venae comitantes. We retrospectively examined our experience in 61 patients who underwent radial forearm free flaps for head and neck reconstruction. Of the 61 patients, 22 anastomoses were hand sewn, and 39 anastomoses were performed using venous couplers. No flap losses occurred in the group in whom venous couplers were used. In addition, no intraoperative thromboses, arterial or venous, were noted with coupler use. Our series demonstrates that the venous coupler is a safe and effective alternative to the hand-sewn anastomosis of the radial forearm free flap venous comitantes in head and neck reconstruction.
Assuntos
Antebraço/irrigação sanguínea , Retalhos de Tecido Biológico , Neoplasias de Cabeça e Pescoço/cirurgia , Microcirurgia , Procedimentos de Cirurgia Plástica , Artéria Radial/cirurgia , Adulto , Idoso , Anastomose Cirúrgica/métodos , Drenagem/métodos , Feminino , Retalhos de Tecido Biológico/irrigação sanguínea , Humanos , Masculino , Pessoa de Meia-Idade , Artéria Radial/fisiopatologia , Procedimentos de Cirurgia Plástica/métodos , Reprodutibilidade dos Testes , Estudos Retrospectivos , Resultado do Tratamento , VeiasRESUMO
PURPOSE: Although no specific delay threshold after diagnosis of breast cancer has been demonstrated to affect outcome, delays can cause anxiety, and surgical waiting time has been suggested as a quality measure. This study was performed to determine the interval from presentation to surgery in Medicare patients with nonmetastatic invasive breast cancer who did not receive neoadjuvant chemotherapy and factors associated with a longer time to surgery. METHODS: Medicare claims linked to Surveillance, Epidemiology, and End Results data were reviewed for factors associated with delay between the first physician claim for a breast problem and first therapeutic surgery. RESULTS: Between 1992 and 2005, 72,586 Medicare patients with breast cancer had a median interval (delay) between first physician visit and surgery of 29 days, increasing from 21 days in 1992 to 32 days in 2005. Women (29 days v 24 days for men; P < .001), younger patients (29 days; P < .001), blacks and Hispanics (each 37 days; P < .001), patients in the northeast (33 days; P < .001), and patients in large metropolitan areas (32 days; P < .001) had longer delays. Patients having breast conservation and mastectomies had adjusted median delays of 28 and 30 days, respectively, with simultaneous reconstruction adding 12 days. Preoperative components, including imaging modalities, biopsy type, and clinician visits, were also each associated with a specific additional delay. CONCLUSION: Waiting times for breast cancer surgery have increased in Medicare patients, and measurable delays are associated with demographics and preoperative evaluation components. If such increases continue, periodic assessment may be required to rule out detrimental effects on outcomes.
Assuntos
Neoplasias da Mama/cirurgia , Listas de Espera , Idoso , Idoso de 80 Anos ou mais , Neoplasias da Mama/diagnóstico , Feminino , Humanos , Masculino , Mastectomia , Medicare/estatística & dados numéricos , Programa de SEER , Fatores de Tempo , Estados UnidosAssuntos
Colágeno/uso terapêutico , Antebraço/cirurgia , Doadores Vivos , Procedimentos de Cirurgia Plástica/métodos , Retalhos Cirúrgicos , Cicatrização/efeitos dos fármacos , Seguimentos , Glossectomia , Humanos , Estudos Retrospectivos , Pele Artificial , Neoplasias da Língua/cirurgia , Resultado do TratamentoAssuntos
Terapia Neoadjuvante , Neoplasias dos Seios Paranasais/cirurgia , Carcinoma/patologia , Carcinoma/cirurgia , Carcinoma Neuroendócrino/patologia , Carcinoma Neuroendócrino/cirurgia , Humanos , Estadiamento de Neoplasias , Neoplasias dos Seios Paranasais/patologia , Complicações Pós-Operatórias , Radioterapia Adjuvante , Procedimentos de Cirurgia PlásticaAssuntos
Neoplasias da Mama/terapia , Algoritmos , Anticorpos Monoclonais/uso terapêutico , Anticorpos Monoclonais Humanizados , Inibidores da Aromatase/uso terapêutico , Mama/efeitos da radiação , Neoplasias da Mama/tratamento farmacológico , Neoplasias da Mama/metabolismo , Neoplasias da Mama/mortalidade , Neoplasias da Mama/patologia , Neoplasias da Mama/cirurgia , Terapia Combinada , Feminino , Humanos , Metástase Linfática , Mastectomia , Terapia Neoadjuvante , Invasividade Neoplásica , Recidiva Local de Neoplasia/prevenção & controle , Estadiamento de Neoplasias , Neoplasias Hormônio-Dependentes/tratamento farmacológico , Neoplasias Hormônio-Dependentes/metabolismo , Pós-Menopausa , Pré-Menopausa , Ensaios Clínicos Controlados Aleatórios como Assunto , Receptor ErbB-2/metabolismo , Moduladores Seletivos de Receptor Estrogênico/uso terapêutico , Biópsia de Linfonodo Sentinela , Tamoxifeno/uso terapêutico , TrastuzumabRESUMO
PURPOSE: The purpose of this study was to evaluate the likelihood of complications and cosmetic results among breast cancer patients who underwent modified radical mastectomy (MRM) and breast reconstruction followed by radiation therapy (RT) to either a temporary tissue expander (TTE) or permanent breast implant (PI). METHODS AND MATERIALS: Records were reviewed of 74 patients with breast cancer who underwent MRM followed by breast reconstruction and RT. Reconstruction consisted of a TTE usually followed by exchange to a PI. RT was delivered to the TTE in 62 patients and to the PI in 12 patients. Dose to the reconstructed chest wall was 50 Gy. Median follow-up was 48 months. The primary end point was the incidence of complications involving the reconstruction. RESULTS: There was no significant difference in the rate of major complications in the PI group (0%) vs. 4.8% in the TTE group. No patients lost the reconstruction in the PI group. Three patients lost the reconstruction in the TTE group. There were excellent/good cosmetic scores in 90% of the TTE group and 80% of the PI group (p = 0.22). On multivariate regression models, the type of reconstruction irradiated had no statistically significant impact on complication rates. CONCLUSIONS: Patients treated with breast reconstruction and RT can experience low rates of major complications. We demonstrate no significant difference in the overall rate of major or minor complications between the TTE and PI groups. Postmastectomy RT to either the TTE or the PI should be considered as acceptable treatment options in all eligible patients.
Assuntos
Implantes de Mama , Neoplasias da Mama/radioterapia , Mamoplastia/efeitos adversos , Dispositivos para Expansão de Tecidos , Adulto , Idoso , Idoso de 80 Anos ou mais , Análise de Variância , Neoplasias da Mama/cirurgia , Estética , Feminino , Seguimentos , Humanos , Mamoplastia/métodos , Mastectomia Radical Modificada/métodos , Pessoa de Meia-Idade , Complicações Pós-Operatórias/etiologia , Dosagem Radioterapêutica , Análise de Regressão , Reoperação , Estudos Retrospectivos , Parede Torácica/efeitos da radiação , Resultado do TratamentoRESUMO
Breast cancer is common in older women, and the segment of the U.S. population aged 65 years and older is growing rapidly. Consequently, awareness is increasing of the need to identify breast cancer treatment recommendations to assure optimal, individualized treatment of older women with breast cancer. However, the development of these recommendations is limited by the heterogeneous nature of this population with respect to functional status, social support, life expectancy, and the presence of comorbidities, and by the underrepresentation of older patients with breast cancer in randomized clinical trials. The NCCN Breast Cancer in the Older Woman Task Force was convened to provide a forum for framing relevant questions on topics that impact older women with early-stage, locally advanced, and metastatic breast cancer. The task force is a multidisciplinary panel of 18 experts in breast cancer representing medical oncology, radiation oncology, surgical oncology, geriatric oncology, geriatrics, plastic surgery, and patient advocacy. All task force members were from NCCN institutions and were identified and invited solely by NCCN. Members were charged with identifying evidence relevant to their specific expertise. During a 2-day meeting, individual members provided didactic presentations; these presentations were followed by extensive discussions during which areas of consensus and controversy were identified on topics such as defining the "older" breast cancer patient; geriatric assessment tools in the oncology setting; attitudes of older patients with breast cancer and their physicians; tumor biology in older versus younger women with breast cancer; implementation of specific interventions in older patients with breast cancer, such as curative surgery, surgical axillary staging, radiation therapy, reconstructive surgery, endocrine therapy, chemotherapy, HER2-directed therapy, and supportive therapies; and areas requiring future studies.
Assuntos
Neoplasias da Mama/epidemiologia , Neoplasias da Mama/terapia , Fatores Etários , Idoso , Idoso de 80 Anos ou mais , Antineoplásicos/uso terapêutico , Neoplasias da Mama/patologia , Feminino , Humanos , Comunicação Interdisciplinar , Expectativa de Vida , Masculino , Pessoa de Meia-Idade , Estadiamento de Neoplasias , Equipe de Assistência ao Paciente , Estados Unidos/epidemiologiaRESUMO
OBJECTIVES: Cosmetic surgery procedures increase in incidence annually, with 11 million performed in 2006. Because breast cancer is the most frequently occurring malignancy in women, a personal history of cosmetic surgery in those undergoing treatment for breast cancer is becoming more common. METHODS: This review identified key studies from the PubMed database, to consolidate existing data related to treatment of breast cancer after plastic surgery. Data were reviewed for factors affecting breast cancer treatment after breast augmentation, breast reduction, abdominoplasty, and suction lipectomy. RESULTS: There are little comprehensive data on the management of breast cancer after plastic surgical procedures. Plastic surgery may affect diagnostic imaging, surgical options, and radiotherapy management. Breast augmentation and reduction are two of the most common cosmetic procedures performed and knowledge of their influence on the incidence, diagnosis, and treatment of breast cancer is important for proper management. CONCLUSIONS: Plastic surgery does not significantly affect breast cancer outcomes but does present management challenges that must be anticipated when deciding various treatment options. Knowledge of the existing literature may be helpful in discussing those options with patients and planning the multidisciplinary approach to this malignancy.
Assuntos
Neoplasias da Mama/diagnóstico , Neoplasias da Mama/terapia , Implantes de Mama , Feminino , Humanos , Mamoplastia , Mastectomia , Radioterapia , Recidiva , Análise de SobrevidaRESUMO
This study investigates the osseointegration of poly(propylene fumarate) (PPF) with beta-tricalcium phosphate (beta-TCP) scaffolds in a critical-size (diameter, 1.6 cm), cranial defect in 4-month-old rabbits (n = 51), killed at 6 or 12 weeks. Two molecular weights of PPF were used to produce bilayer scaffolds with 0.5-mm solid external and 2.0-mm porous internal layers. The porous layer was infused with bone marrow aspirate, with half the animals receiving 0.8 microg of transforming growth factor beta2 (TGF-beta2). No foreign body or inflammatory response was observed externally or on histological examination of explants. Statistical analysis of histological areal and linear measures of new bone formation found significantly more bone at the later sacrifice time, followed by implants receiving TGF-beta2, followed by low molecular weight PPF implants. Approximately 40% of the explants were tested for incorporation strength with a one-point "push-in" test. Because no permanent fixation was used, implant strength (28.37-129.03 N; range, 6.4 to 29.0 lb of resistance) was due entirely to new bone formation. The strongest bone was seen in implants receiving TGF-beta2-infused marrow in animals killed at 12 weeks. These results support the use of PPF as an osteogenic substrate and future research into preoperative fabrication of critical size and supercritical-size cranial prosthetic implants.