Neoplasms

Symptoms and General Pathology

All Conditions

Musculoskeletal Diseases

Cysts

Bone Cysts

Bone Neoplasms

Bone Diseases

Intraoperativ application of medical device: CERAMENT™ \|BONE VOID FILLER 5cc/10cc/18cc

Implantation of bi-phasic ceramic bone substitute to provide bone generation and bone remodeling in patients with benign bone tumors.

CERAMENT™ |BONE VOID FILLER

Jacek Kaczmarczyk, Prof.MD,PhD

The purpose of this study is to assess the ability a injectable bi-phasic ceramic bone substitute to provide bone generation and bone remodeling in patients with benign bone tumors.

The aim of the study is to assess the usefulness of injectable bi-phasic ceramic bone substitute (CERAMENT™ \|BONE VOID FILLER) in patients with benign bone tumors. The primary objectives is to:

1. Assess the ability of bi-phasic ceramic bone substitute to provide bone generation and bone remodeling in patients with benign bone tumors.
2. Assess the safety of bi-phasic ceramic bone substitute as measured by device complaint/Adverse Events monitoring and documentation of subsequent surgical procedure.
3. In the case of bone cysts assess the ability of bi-phasic ceramic bone substitute to transform into bone and possibly induce bone formation in regions of the cyst not filled with the product.

Benign bone tumors are often treated with intralesional curettage which creates a bone defect that can be filled with e.g. demineralized bone matrix, autologous bone, ceramic bone substitutes or polymethylmetacrylate cement.

Autograft has been considered the golden standard because it possesses all three of the essential elements required for an optimal bone graft, but is associated with morbidity at the donor site and is limited in supply. Allograft has been employed as a good alternative to autograft but the concern for potential disease transmission remains. Synthetic bone graft substitutes have been gaining popularity as viable alternatives for void and defect filling eliminating the concerns with autograft and allograft. These synthetic bone substitutes have invariably been based on calcium phosphate and/or calcium sulfate materials which are osteoconductive and facilitate bone remodeling, although side effects such as drainage and wound complications slow remodeling to bone or negligible bone generation have limited their use. Thus, new synthetic bone substitutes with described positive effects in vertebroplasty, osteotomy, and smaller trauma defects merit further investigation also in treatment of larger bone defects.

In a prospective series, patients with benign bone tumors were treated by minimal invasive intervention with a bi-phasic and injectable ceramic bone substitute (CERAMENT™ BONE VOID FILLER), composed of 60% weight synthetic calcium sulfate (CaS) and 40% weight hydroxyapatite (HA) powder was mixed with a water-soluble radio-contrast agent iohexol (180 mg/ml) to make the material radiopaque. The defects were treated by either mini-invasive surgery (solid tumors) or percutaneous injection (cysts) and followed clinically and radiologically for 12 months. CT scan was performed after 12 months to confirm bone remodeling of the bone substitute. All patients were allowed full weight bearing immediately after surgery.

Complete Twelve Month Bone Remodeling With a Bi-phasic Injectable Bone Substitute in Benign Bone Tumors

A Prospective, Longitudinal Patient Study on CERAMENT™|BONE VOID FILLER in Benign Bone Tumors

Evaluate bone healing and remodeling at 12 month by X-ray and CT-scan using Modified Neer classification of radiological results.

Calculate the pre-operative volume of the cyst, document the volume of product placed into the cyst and the volume of bone formed at 12 months.

In the case of bone cysts assess the ability of CERAMENT™ \|BONE VOID FILLER to transform into bone and possibly induce bone formation in regions of the cyst not filled with the product.

Assess the safety of CERAMENT™\|BONE VOID FILLER as measured by number of any device complaint/Adverse Event and any subsequent surgical procedure.

Poznan University of Medical Sciences

Principal Investigator

Wounds and Injuries

Fractures, Bone

All Drugs and Chemicals

Bone Density Conservation Agents

Calcium

Calcium, Dietary

Mehan ALTAIFI

Nathalie BAUDRY

Sébastien PARRATTE, MD, Prof.

Sébastien PARRATTE, MD, Prof

CPC REGISTRY is a multi-center, international, prospective, open-label, observational study on the use of injectable calcium phosphate cements for the treatment of bone defects in adults. All patients will be treated with any of the two injectable calcium phosphate bone substitutes (GRAFTYS®HBS/GRAFTYS®Quickset or their private labels) according to standard clinical practice and according to the information provided by GRAFTYS manufacturer in respective device Instructions For Use (IFU).

The objective of this observational prospective study is to collect safety and performance data relating to the use of injectable Calcium Phosphate Cements "GRAFTYS®HBS/GRAFTYS®Quickset (or their private labels)" in routine clinical practice from various international hospitals. Therefore this observational study will allow to support data about risk management (established at the end of the product development); and to enhance the current clinical evaluation of products with new clinical data (for longer follow-up). The collected data of this observational study will be "non-identifying data". The patient must have signed a Written Consent Form (for data collection) prior to any data being entered into the electronic Case Report Form.

Patients will be followed as per local standard medical practices of the center for two years. Five follow-up visits/phone calls will be collected (at 3 months (+/-14 days), 6 months (+/- 14 days), 9 months (+/-21 days), 12 months (+/- 30 days) and 24 months (+/-60 days)). Each visit/phone call includes the collection of Adverse Events, the measurement of health status (quality of life and functional scores) and the X-ray scoring (if X-ray imaging is available). No additional exams (other than the routine clinical practice) are requested. The surgeons have to follow their usual practices (e.g. X-Rays have to be performed only if they are scheduled in the routine clinical practice).

All Adverse Events will be collected and monitored at each follow-up visit or follow-up phone call. All Serious Adverse Events must be described via a Serious Adverse Event form in e-CRF and all Adverse Device Effects must be described via a "Product Complaint Form" in e-CRF.

Descriptive analyses will be performed in order to describe: nature of adverse events, their distribution and frequency. Moreover, all factors which may appear predictive for the rate of adverse events will be analyzed (age, sex, amount of CPC injected, delivery system used, diabetes history, smoking habits, alcohol consumption, concomitant treatments/diseases...). For all time-dependent events, life-tables will be able to calculate using the Kaplan Meier estimate method, for a period starting on the date of the procedure up to and including the 24-months follow-up visit.

Calcium Phosphate Cement Registry (CPC Registry)

Observational Prospective Multi-center International Study on the Use of Injectable Calcium Phosphate Cements for the Treatment of Bone Defects in Adults.

Rate of Adverse Events related to bone substitutes (registry devices) for the follow-up period of patients.

Technical Success rate defined as successful delivery of the bone substitute in the target defect bone without evidence of delivery device or bone substitute malfunction. (NOTE: Malfunction is definied as a failure of the medical device to perform in accordance with its intended purpose when used in accordance with the Instructions For Uses (IFU)).

Device deficiency is defined as an inadequacy of a medical device with respect to its identity, quality, durability, reliability, safety or performance.

NOTE: Device deficiencies include malfunctions, use errors, and inadequate labelling.

Serious Adverse Event is defined as any adverse event that:

1. Led to a death,
2. Led to serious deterioration in health of the subject that either resulted in:

   1. a life-threatening illness or injury, or
   2. a permanent impairment of a body structure or a body function, or
   3. in-patient or prolonged hospitalization, or
   4. medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function.
3. Led to fetal distress, fetal death or a congenital abnormality or birth defect.

X-ray scoring systems have been implemented according to the medical literature criteria. For trauma defects/arthrodesis, the results are scored using the criteria proposed by Lane and Sandhu (bone formation, union and remodeling) and also including a bone substitute resorption (radiolucency) criteria. As for prosthesis revision/cavity defects, the scoring system includes bone substitute resorption, bone formation, remodeling and presence or absence of a radiolucent line between the bone and the cement/implant. The maximum score for both groups (trauma/arthrodesis \& cavity filling/arthroplasty) is 10/10 (excellent consolidation/excellent secondary stabilization) and the minimum score is 0/10 (no consolidation/no secondary stabilization).

This health status information is collected before and after a procedure and provides an indication of the clinical outcomes or quality of care delivered to patients. EQ-5D-3L paper questionnaire will be self-administered or it will be administered to patient via a telephone interview. The EQ-5D-5L still consists of 2 parts - the EQ-5D-5L descriptive system and the EQ VAS. The descriptive system comprises 5 dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression). Each dimension has 3 levels: no problems, some problems, extreme problems. EQ VAS is a scale on which the "best imaginable health state" is marked 100 and the "worst imaginable state" is marked 0.

Functional scores are used to monitor the patient progress. The questionnaires concern the degree of difficulty (level of function) that the patient experienced in performing usual daily activities and higher level activities due to his bone defect. Therefore, the type of functional score depends on the skeletal region impacted by the bone defect:

* Hand/wrist/ elbow/shoulder: Quick-DASH score (Disabilities of Arm, Shoulder \& Hand).
* Knee: KOOS-PS (Knee Injury \& Osteoarthritis Outcome Score- Physical function Short form)
* Hip: HOOS-PS (Hip disability and Osteoarthritis Outcome Score- Physical function Short form)
* Foot/Ankle: Kitaoka \& al's criteria, AOFAS Ankle-Hindfoot Scale; Forefoot Scale; Midfoot scale.

Surgeon's Satisfaction survey with registry device (about mixing ability, injecting ability and moldability) thanks to a 100-mm Visual Analog Scale (VAS). A score of zero indicated absolutely inacceptable, while a score of 100 indicated very satisfying.

Clinfile

Graftys SA

Pathological Conditions, Anatomical

Hormones

Curettage with puncture (C \& P) will be performed alone

A predetermined amount of Vitoss morsels will be injected following the curettage and puncture (C \& P)

A curette will be inserted to scrape the contents of the cyst (curettage) and a hole in the cyst wall will be made (puncture) near the bone marrow cavity

Curettage with puncture (C & P)

A small surgical instrument with a rounded edge designed for scraping

Curette

A bone substitute intended for use as a filler for voids or gaps in bones

Vitoss morsels

Project Manager

Elisabeth Clarke

Martin Morrison III

Carly Strohbach

Jamie Burgess

Joseph A Janicki

Julie Titter

Anna Vergun

Grace Anand

Vinitha R Shenava

Melissa Formosa

Brian Loh

Yoga Dhanapala

Elaine Joughin

Harpreet Chhina

Tony Cooper

Kishore Mulpuri

Jennifer Hurry

Karl Logan

Jacob Davidson

Debra Bartley

Holly Livock

Sasha Carsen

Julie Shiu

Sevan Hopyan

Emma Spink

Dan Perry

Kim Gardiner

Andreas Roposch

Imelda Mayor

Mohamed Kenawey

Rebecca Harmer

Tim Theologis

Aimee Corcoran

Nicolas Nicolaou

James G. Wright

Simple bone cysts (SBCs) are cysts filled with fluid that occur most frequently in the long bones (arms or legs) of children. There are many ways to treat SBCs but it is unclear if one is better than another. The purpose of this research trial is to compare the effectiveness of two common treatments that are used by surgeons today.

In general, few randomized clinical trials have been undertaken in paediatric orthopaedics, and only one to date has addressed the problem of simple bone cysts (SBCs). Also known as unicameral bone cysts, they are the commonest bone lesion in children. Despite general opinion, these cysts do not resolve at skeletal maturity.

Many forms of treatment have been recommended but none, including the popular methods of corticosteroid or bone marrow injections, have reliably eradicated SBC. Although the lesions are considered benign (non-cancerous), they cause pain, frequently interfere with function, dramatically restrict play activity, may re-fracture leading to growth arrest and/or deformity, and cause enormous anxiety for children and their families.

With a well-developed network of surgeons and researchers, we will provide evidence comparing the effectiveness of two treatment interventions for SBC. More specifically, our goals for this study are:

1. to compare the rate of radiographic healing between two standard treatments including curettage with puncture alone, and curettage with puncture followed by injection with Vitoss morsels;
2. to identify prognostic radiographic factors associated with simple bone cyst healing and fracture;
3. to determine the impact of simple bone cyst on children/family functioning.

Simple Bone Cysts in Kids

Simple Bone Cysts in Kids (SBoCK)

Healing will be graded according to a 4-point modified Neer's classification by radiologists

Cyst features (ie. appearance, size) will be described or measured from X-rays taken annually after treatment

Function in participants will be evaluated using self-reported questionnaires for activity level, perception of illness, and pain annually after treatment

Canadian Institutes of Health Research (CIHR)

The Hospital for Sick Children

Orthopaedic Surgeon

Patients with bone cyst defect are injected with mesenchymal cells.

injection of mesenchymal cells to bone cyst defect

cell injection

Hamid Gourabi, PhD

Mohammad reza Baghban Eslami Nejad, PhD

Mohssen Emadeddin, MD

Ahmad Vosough, MD

Nasser Aghdami, MD,PhD

There are two types of bone cysts, unicameral and aneurismal. These cysts happen to anyone, but they are most commonly seen in children and young adults while their bones are still growing. Living with a bone cyst and determining treatment options depend on the type of cyst.

Non-surgical treatments for unicameral bone cysts involves repeated X-rays in individuals who do not experience any symptoms.

Surgical removal of a unicameral bone cyst is needed if it becomes especially painful, or the area of the bone starts to thin out. The investigators aim to assess the clinical efficacy and side effects of mesenchymal stem cells seeded on bone matrix in repairing bone cyst.

Bone cysts are benign lesions usually discovered in children from age of 5 to 15 years. Treatment options include observation, corticosteroid injection and surgery. Sometimes the risk of surgery is comparable to the likelihood of fracture without treatment. In orthopedic surgery, bone chips , various types of ceramics, natural and synthetized bone mineral hydroxyapatite and tricalcium phosphate, as well as numerous polymers and co-polymers of alfa-hydroxy acids are used to perform as an osteoconductive and rarely osteoinductive factor to help bone formation.Some evidence demonstrated that bone marrow mesenchymal stem cells deposited on the surface of this constructs enhance its osteogenic differentiation. In this study the investigators seeds cultured bone marrow derived mesenchymal stem cells on bone matrix, to evaluate its therapeutic potential in repairing unicameral or aneurysmal bone cyst.This composite is placed in the bone cyst after its curettage during a surgery.Post-operation assessment is done by X-Ray examination and MRI at 1, 2, 6, and 12 months after treatment.

Treatment Of Bone Cyst With Bone Marrow Mesenchymal Cell Transplantation

Effect of Bone Marrow-derived Mesenchymal Stem Cell Transplantation in Reconstructing Bone Defects.

Defect of bone due to cyst fulfill after cell transplantation.

Evaluate effect of mesenchymal cell transplantation to fulfill the defect of bone cyst.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Complete Twelve Month Bone Remodeling With a Bi-phasic Injectable Bone Substitute in Benign Bone Tumors	NCT02567084	Bone Cyst	CERAMENT™ \|BONE...	7 Years - 75 Years	Poznan University of Medical Sciences
Calcium Phosphate Cement Registry (CPC Registry)	NCT02575352	Bone Disease Fracture Bone Bone Cyst		18 Years -	Graftys SA
Simple Bone Cysts in Kids	NCT02193841	Bone Cyst	Curettage with ... Curette Vitoss morsels	2 Years - 21 Years	The Hospital for Sick Children
Treatment Of Bone Cyst With Bone Marrow Mesenchymal Cell Transplantation	NCT01207193	Bone Cyst	cell injection	12 Years - 75 Years	Royan Institute

Spots Global Cancer Trial Database for bone cyst

Every month we try and update this database with for bone cyst cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for bone cyst

Every month we try and update this database with for bone cyst cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for bone cyst cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.