Neoplasms

Symptoms and General Pathology

All Conditions

Wounds and Injuries

Musculoskeletal Diseases

Neoplasm Metastasis

Fractures, Bone

Bone Neoplasms

Fractures, Spontaneous

standard length femoral stem arthroplasty applied for patients with proximal femoral metastasis either impending or pathological fracture

long femoral stem arthroplasty applied for patients with proximal femoral metastasis either impending or pathological fracture

using lateral approach to the hip we will compare the effect of femoral stem length on the oncological and functional outcomes in patients with proximal femoral metastasis.hip arthroplasty is a surgical procedure that involves changing the head of the femur (the ball) with or without replacing the articular surface of the acetabulum (the socket ).and replacing it with metal head based on a stem covered with cement to fix it to the bone of the femur.

femoral stem in hip arthroplasty

Proximal femoral metastatic disease is a common cause of morbidity and mortality in cancer patients.protecting the entire femur using long nail or long femoral stem was hypothesized to prevent future fracture.However we believe that long stem isn't always necessary and won't decrease the complication rate.noting it's increased complication rate in this high risk patient category .

Skeletal metastasis is the third most common site of cancer metastasis after the lungs and liver, almost all patients with metastatic prostate cancer will have bone metastasis. And about 90% of patients dying from breast cancer has skeletal metastasis.

The most common site to which cancer metastasize to long bones is the proximal femur, especially to the intertrochanteric region and femoral neck, contributing to increasing incidence of impending and pathologic fractures of this site.(8) Recent advances in cancer treatment increased the longevity of patients, with subsequent increase in morbidity of metastatic disease and increased number of patients living longer with this condition .

To date, long femoral stem is most frequently used in cases of pathological and impending proximal femoral fractures. Its use is believed to add more stability and prophylactically protect the entire femur from newly developed distal lesions. However, long stems has more operative time, more cardiopulmonary complications and are more technically demanding compared to standard femoral stems arthroplasty.(5) Recent retrospective study by Xing et al reported comparable outcomes between standard, medium and long stems and concluded that the routine use of long stems is unjustified.Another recent report by Joel et al investigated the use of long femoral stem in 22 limbs, they reported no hardware failure with no cases of intraoperative cardiopulmonary complications, however they recommended larger comparative trials with rigorous methods to investigate the functional outcomes and complications of long femoral stems in proximal femoral metastatic lesions.

In face of the potential advantages in this patient population, the goal of this study is to investigate the use of standard length femoral stems and its results compared to long femoral stems in proximal femoral metastasis .

two comparative groups, standard and long femoral stem arthroplasty

only participants were blinded from treatment group.

Length of the Femoral Stem in Arthroplasty Done for Patients With Proximal Femoral Metastatic Lesion

Cemented Long Versus Standard Femoral Stem Arthroplasty for Proximal Femoral Metastasis

The Musculoskeletal Tumor Society (MSTS) scoring system is a disease-specific instrument to determine the physical and mental health for patients with extremity sarcoma

is a simple measure of functional status. It has scores ranging from 0 to 5

postoperative infection (superficial or deep),dislocation

Ain Shams University

Femoral Fractures

Neoplastic Processes

The patients receives bone fixation with short intramedullary nails for extremity metastases.

The patients receives bone fixation with long intramedullary nails for extremity metastases.

Intramedullary nailing is a method of internal fixation used to treat fractures. An intramedullary nail is a metal rod forced into the marrow canal of a bone to stabilize and align fractures. Participants in this group will be fixed with a shorter intramedullary nail (defined as defined as less than 2/3 of the patient's femur) for proximal femoral (impending) pathological fractures.

Internal fixation with short intramedullary nails

Intramedullary nailing is a method of internal fixation used to treat fractures. An intramedullary nail is a metal rod forced into the marrow canal of a bone to stabilize and align fractures. Participants in this group will be fixed with a longer intramedullary nail (defined as greater than 2/3 of the patient's femur) for proximal femoral (impending) pathological fractures.

Internal fixation with long intramedullary nails

Hsiang Chieh Hsieh, MD

The goal of this interventional randomized controlled trial is to compare the clinical outcomes in treating extremities pathological fractures (fractures of limbs caused by metastatic tumors) or impending pathological fractures with short or long intramedullary nails. The main questions it aims to answer are:

1. What is the rate of developing new distant metastasis of the operated extremities?
2. Does treating extremities (impending) pathological fractures with long intramedullary nails have lower or similar reoperation rate than the short nails?
3. Are there any differences when comparing the surgical-related complication, functional outcomes and life quality assessment between treating extremities (impending) pathological fractures with long or short intramedullary nails.

Participants who meet surgical indication will be randomized into either the long or short intramedullary nail group after informed consent. The patient will receive bone fixation with the corresponding prosthesis.

Participants will be randomized into either long or short intramedullary nail groups. Participants in the long intramedullary nail group will be fixed with a longer intramedullary nail (defined as greater than 2/3 of the patient's femur) for proximal femoral (impending) pathological fractures, while patients in the short intramedullary nail group will be fixed with a shorter intramedullary nail (defined as less than 2/3 of the patient's femur) for proximal femoral (impending) pathological fractures. Follow-up will be performed at 1, 3, 6, and 12 months after surgery to analyze the patient's function, blood sampling values, and imaging follow-up. The functional capacity will be evaluated by PROMIS questionnaire.

Short Versus Long Intramedullary Nails in the Treatment of Proximal Femur Metastasis.

Compare the Efficacy of Long-nailed and Short-nailed Fixation for Proximal Femur Metastasis - a Non-inferior Randomized Controlled Trial

Percentage of patients receiving revision surgery within 1 year after the intervention. The primary outcome should be compared using non-inferior tests. The non-inferior margin was pre-specified at 25.4%.

The Patient-Reported Outcomes Measurement Information System (PROMIS) is a set of person-centered measures that evaluates physical, mental, and social health in adults and children. It's used to measure symptoms and other aspects of health status in a wide variety of chronic diseases. PROMIS-29 is a particular version of this system that covers multiple domains of health and function. It consists of 29 items in total, spanning seven domains: physical function, anxiety, depression, fatigue, sleep disturbance, ability to participate in social roles and activities, and pain interference. Each domain has four questions, with the exception of the pain interference domain, which has five. Each question is scored from 1-5, the higher score indicates better function or quality of life. The sum of the PROMIS results in the raw score, which lies between 4 and 20. There's also a single question evaluating pain intensity, as assessed by pain intensity numeric rating scale.

Cardiopulmonary complication includes the following events developing within 30 days after the intervention: O2 desaturation, shock, embolic event, or coma and death.

Percentage of demise at 1,3,6,12 months after the intervention

Newly formed metastatic lesions on the same limb distant to the operation site within 1 year after the intervention

Utility comparison using Patient-Reported Outcomes Measurement Information System-29 (PROMIS-29) questionnaire

National Taiwan University Hospital, Yun-Lin Branch

National Taiwan University Hospital Hsin-Chu Branch

National Taiwan University Hospital

Skin and Connective Tissue Diseases

Breast Neoplasms

Disease Progression

Breast Diseases

Skin Diseases

Patients with potentially unstable spinal metastases of breast cancer

Yuhui Shen, Ph.D., M.D.

Weibin Zhang, Ph.D., M.D.

Qin He, M.D.

Shizhao Zang, M.D.

Qiyuan Bao, Ph.D., M.D.

Xiaosong Chen, M.D.

The purpose of this study is to identify potential risk factors for and determine the rate of pathological fracture for patients which having spine metastases from breast cancer and be defined as potentially unstable (SINS 7-12) according to the Spinal Instability Neoplastic Score (SINS). The investigators' analysis will provide robust data about the development of spinal instability and help identify the optimal timing of local surgery treatment.

Considering the concept of spinal instability remains important in the clinical decision-making process for patients with spine metastases, the Spine Oncology Study Group (SOSG) devised an 18-point SINS, which proved reliable and has been widely used in clinical practice. Scores of 0-6, 7-12, 13-18 are considered stable, potentially unstable, and unstable, respectively. Lesions with a low SINS (score 0-6) do not requires surgical interventions, whereas a high SINS (score 13-18) predicts the need for surgical stabilization to restore spinal stability. However, treatment strategy of intermediate SINS (score 7-12) lesions remains ambiguous owing to the uncertainty of spinal stability. With the duration of spinal metastases, some potentially unstable lesions turn to be stable while some turn to be unstable, and several factors such as tumor involvement for vertebral body, radiotherapy may account for different outcomes. Owing to the relatively weaker growth and invasion ability of breast cancer cells compared to other solid tumors such as lung cancer and liver cancer, patients with breast cancer and spinal metastases have longer life expectancy. Reasonable and prompt local surgical intervention to restore spinal stability can achieve pain relief and better quality of life effectively. Moreover, most spinal metastases from breast cancer show lytic or mixed lytic-blastic bone lesions, which exacerbates the spinal stability and results in pathological fracture. Thus, investigators focus on patients which having spinal metastases from breast cancer and an intermediate SINS (score 7-12) to explore the rate of pathological fracture and relevant risk factors. This study will help spine surgeon to identify who could benefit from a prophylactic stabilization procedure with high risk of pathological fracture and when is the best timing of surgery.

Pathological Fracture in Potentially Unstable Spinal Metastases of Breast Cancer

A Pilot Study of Pathological Fracture Progression and Related Risk Factors for Patients With Potentially Unstable Spinal Metastases of Breast Cancer

Pathological fracture will be detected using Magnetic Resonance Imaging (MRI)

The Spine Instability Neoplastic Score (SINS) is a comprehensive classification system that can aid in predicting spine stability of neoplastic lesions. The 18-point SINS includes global spinal location of the tumor (score 0-3), type and presence of pain (score 0-3), bone lesion quality (score 0-2), spinal alignment (score 0-4), extent of vertebral body collapse (score 0-3), and posterolateral spinal element involvement (score 0-3). As the SINS increases, the spine stability of neoplastic lesions turns to be worse

Ruijin Hospital

Principal Investigator

Rare Diseases

Recurrence

Cysts

Bone Cysts

Bone Cysts, Aneurysmal

Pathological Conditions, Anatomical

Bone Diseases

Aneurysmal Bone Cysts

Bone Density Conservation Agents

All Drugs and Chemicals

Denosumab

Patients with aneurismal bone cysts received perioperative denosumab(Xgeva).

Denosumab (Xgeva) 120 mg was given subcutaneously (abdomen wall or upper arms) every 4 weeks (Q4W), with a loading dose on both Day 8 and Day15 of the first cycle， perioperatively.

Denosumab (Xgeva)

The efficacy of traditional therapeutic approaches for aneurysmal bone cysts (ABC), such as surgery, embolization, sclerotherapy and radiotherapy, are often compromised for lesions in axial skeletons and adolescents complicated with pathological fracture. Therefore, denosumab, a new drug that has been successfully used in giant cell tumor of bone but has seldom used in ABC, was used to treat ABC in this trial.

Patients with primary ABC treated with perioperative denosumab in the Musculoskeletal Tumor Center of Peking University People's Hospital between January 2014 and December 2016 will be reported in this trial.Approved by the Ethics Committee of Peking University People's Hospital and with the full informed consent from the patients or their families, all patients received surgery and treatment with denosumab perioperatively. Denosumab 120 mg was given subcutaneously (abdomen wall or upper arms) every 4 weeks (Q4W), with a loading dose on both Day 8 and Day 15 of the first cycle. Meanwhile, all patients were suggested to take 800mg oral calcium supplement every day and avoid any dental or oral surgery (tooth extraction, tooth filling, etc.). Patients were followed once a month since the date of surgery. On follow-up visits, patient-reported adverse reactions, X-ray image of jawbone, serum calcium, alkaline phosphatase, renal and hepatic function, hemoglobin, white blood cell, and platelet count were collected, and histological examinations, radiological examinations (such as X-ray, computed tomography (CT), magnetic resonance image (MRI) and positron emission tomography-computed tomography (PET-CT) and postoperative functional status evaluations by MSTS（Musculoskeletal tumor society） score were conducted.

Patients with recurrent and/or refractory aneurysmal bone cysts treated with denosumab perioperatively.

Denosumab: A Potential Treatment Option for Aneurysmal Bone Cysts

the number of participats (complete response+ partial response according to RECIST 1.1)/ total participants number.

CT or MR proof that the tumor relapse in the primary site by at least two radiologist.

include patient-reported adverse reactions, X-ray image of jawbone, serum calcium, alkaline phosphatase, renal and hepatic function, hemoglobin, white blood cell, and platelet count were collected in follow-up every 3-month.

Peking University People's Hospital

Director, Head of Muscoloskeletal Tumor Center, Principal Investigator, Clinical Professor

Blood and Lymph Conditions

Bone Marrow Diseases

Hematologic Diseases

Patients with lower extremity bone metastases will receive surgical fixation/reconstruction but will not receive any post-operative radiation therapy.

Patients with lower extremity bone metastases will receive surgical fixation/reconstruction and will receive any post-operative radiation therapy.

The post-operative radiation will cover entire prosthesis/surgical fixation device and will consist of the dose fractionation of: 20 Gy in 5 fractions or 30 Gy in 10 fractions.

External beam radiation therapy

Patrick Henry, MD FRCS(C)

The objective of the present study is to evaluate the effectiveness of post-operative radiation therapy in lower extremity bone metastases. This trial will compare the health outcomes of patients receiving radiation therapy after Orthopaedic surgery to patients who will not receive radiation therapy post-surgery. The primary objective of the study is to compare the need for a subsequent surgery at the same treatment site within 12 months of the initial surgery. Additionally, the need for radiation or re-irradiation, functional status, performance status, pain scores, radiologically detected local disease progression, and overall length of survival will be compared at clinical endpoints for the two study arms. It is hypothesized that those randomized to receive post-operative radiation therapy will less likely need a subsequent surgery within the 12 months after the primary surgical intervention. This may optimize the quality of life for this patient population.

The incidence of bone metastases in advanced cancer patients is substantial, representing 70% of all metastatic sites. Approximately 5-10% of all patients with bone metastases develop pathological fractures. Surgical reconstruction can be helpful following fracture or prophylactically in cases of an impending fracture. In these cases, post-operative radiation is the current clinical practice in North America and many countries around the world. Post-operative radiation has the potential to support bone healing and prevent tumor progression while also decreasing the need for subsequent orthopaedic surgeries to the same site. A recent systematic review, however, challenged the evidence on its efficacy and adoption as standard of care in this patient population. As well, post-operative radiation requires additional visits to the radiation centre (associated with added costs and efforts for both the patients and the healthcare system). There is also a "pain flare" phenomenon, in which up to 40% of patients receiving radiation for palliative bone metastases experience pain within 1-5 days following radiation. The pain can last for 10 days and may acutely mask potential clinical benefits of radiation.

Given that there is potential negative impact to these patients who are palliative with a relatively short lifespan, it is important that the efficacy of post-operative radiation is rigorously evaluated.

We propose a multicenter randomized controlled trial to assess the efficacy of post-operative radiation following orthopaedic surgery in patients with lower extremity bone metastases. 300 patients with pending or established lower extremity pathological fracture will be recruited to a trial of surgery alone vs. surgery with post-operative radiation. The primary endpoint is a second surgery to the same site within 12 months. Secondary outcomes include quality of life, pain and functional outcome markers, radiation or re-irradiation as applicable, a second surgery within 24 months for those patients alive, overall survival and cost effectiveness.

Participants will be randomized to receive 1 of the 2 treatment arms.

External Beam Radiation Therapy Post Surgery in Patients With Lower Extremity Bone Metastases Randomized Efficacy Trial

A Phase III Multicenter Randomized Trial Assessing the Efficacy of Post-Operative Conventional External Beam Radiation Therapy Following Orthopaedic Surgery in Patients With Lower Extremity Bone Metastases

Requirement for re-irradiation in arm 2 or radiation in arm 1

Requirement of subsequent surgery past 12 months (between 13 months and 24 months)

The best, median, and worst post-operative functional status and KPS will be derived for each patient, and the Wilcoxin rank sum test will be used to compare the difference between treatment arms

The lowest, median, and worst post-operative pain score will be derived for each patient, and the Wilcoxin rank sum test will be used to compare the difference between treatment arms. The cumulative and mean of analgesic use will presented by treatment arm.

Time to radiological local disease progression is defined as the time from randomization to the date of documented radiological logical disease progression or death whichever comes first.

Quality of life measured measured using EORTC quality of life questionnaire (QLQ)-C15-Pal and EORTC quality of life questionnaire (QLQ)-BM22. This questionnaire includes for multi-item scales and six individual items. All items were scaled from 1 (not at all) to 4 (very much) in which a higher score indicates greater distress in symptom scales while a higher score in functional scale indicates greater functional ability. The EORTC QLQ-BM22 is a 22-item module that addresses disease symptoms related to bone metastasis. It has four subscales (painful sites, pain characteristics, functional interference and psychosocial aspects). All items were scaled from 1 (not at all) to 4 (very much), in which a higher score indicates greater distress in symptom scales while a higher score in functional scale indicates greater functional ability

Overall survival is defined as the time from randomization to the date of death from any cause, or censored at their last known alive data before or on data cutoff date

Determination of the incremental cost-effectiveness by prospectively collecting economic and resource utilization information. The objective is to determine an incremental cost effectiveness ratio reported as a cost per subsequent surgery avoided for both treatment arms. The mean overall cost per patient for each of the two study treatment arms will be calculated to determine the addition cost per surgery avoided.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Length of the Femoral Stem in Arthroplasty Done for Patients With Proximal Femoral Metastatic Lesion	NCT04660591	Metastatic Bone... Pathological Fr... Arthroplasty	femoral stem in...	18 Years -	Ain Shams University
Short Versus Long Intramedullary Nails in the Treatment of Proximal Femur Metastasis.	NCT05969470	Bone Metastases Pathological Fr... Pathological Fr... Pathological Fr...	Internal fixati... Internal fixati...	20 Years -	National Taiwan University Hospital
Pathological Fracture in Potentially Unstable Spinal Metastases of Breast Cancer	NCT03365973	Spinal Metastas... Breast Cancer		18 Years - 65 Years	Ruijin Hospital
Denosumab: A Potential Treatment Option for Aneurysmal Bone Cysts	NCT03415477	Bone Cyst Aneur... Pathological Fr... Recurrent Disea... Refractory Tumo...	Denosumab (Xgev...	12 Years - 65 Years	Peking University People's Hospital
Short Versus Long Intramedullary Nails in the Treatment of Proximal Femur Metastasis.	NCT05969470	Bone Metastases Pathological Fr... Pathological Fr... Pathological Fr...	Internal fixati... Internal fixati...	20 Years -	National Taiwan University Hospital
External Beam Radiation Therapy Post Surgery in Patients With Lower Extremity Bone Metastases Randomized Efficacy Trial	NCT04109937	Bone Metastases Lower Extremity... Pathological Fr... Impending Fract...	External beam r...	18 Years -	Sunnybrook Health Sciences Centre

Spots Global Cancer Trial Database for pathological fracture