Neoplasms

Musculoskeletal Diseases

All Conditions

Bone Neoplasms

Bone Diseases

Commercial resorbable bone graft substitute (Vioxid Ltd)

Bioactive glass (SP53P4)

Hannu T Aro, MD, PhD

This is a randomized clinical trial that will be carried out to examine the use of bioactive glass granules (S53P4) as bone graft substitute in filling small and large bone defects as compared with autogenous and allogeneic bone grafting, respectively.

This a single center randomized trial. The hypothesis of the study is that the selected synthetic bone graft (bioactive glass granules, S53P4, Vivoxid Ltd, Turku, Finland) is as good as traditional autogenous or allogeneic bone grating in filling of non-traumatic bone defects. A total of 48 patients (stratified into two groups) will be included. The underlying bone disease will include common bening and semi-malign bone tumors (such as enchondroma and giant cell tumors) as well as tumor-like conditions (such as fibrous dysplasia, fibrous cortical defect, solitary bone cysts, aneurysmatic bone cyst).

Group I (n=24) will include patients with small benign bone lesions amenable to evacuation and autogenous bone grafting as standard of care. The patients will be randomized to autogenous bone grafting or bioactive glass granule filling. The follow-up examinations up to 52 weeks will include plain X-rays at 4, 26, and 52 weeks as well as MRI ad 4 and 52 weeks.

Group II (n=24) will include patients with a large bone defect. As the selection criteria, large defects have been defined to be defects which need allogeneic bone grafting. The patients will be randomized to allogeneic bone grafting or bioactive glass granule filling. The patients will be followed up to 52 weeks. The follow-up examinations will include X-rays at 4, 26 and 52 weeks as well as PET/CT imaging and MRI at 4 weeks and 52 weeks.

Bioactive Glass Granules in Filling of Bone Defects

Bioactive Glass Granules as Bone Graft Substitute in Filling Material of Bone Defects

The healing of bone defects will be examined by plain X-rays and MRI

The outcome of the surgical procedure (i.e. the subjective recovery of the patients) will be evaluated by means of Rand-36 scoring system

PET imaging will be applied to measure blood flow and metabolic activity at the surgical site

Turku University Hospital

Hannu T Aro

Symptoms and General Pathology

Cysts

Bone Cysts

Pathological Conditions, Anatomical

20 bone cysts (in 20 patients) are filled with bioactive glass

20 bone cysts (in 20 patients) are filled with allogenic bone

Comparison of bioactive glass to allogenic bone in pediatric bone cysts

Bioactive glass

Johanna Syvänen, PhD

Ilkka Helenius, Prof

Yrjänä Nietosvaara, PhD

Jenni Jalkanen, Phd

Juha-Jaakko Sinikumpu, Prof

Anne Salonen, PhD

The Finnish Paediatric Orthopedic Study Group will perform a prospective, randomized, multicenter, clinical trial comparing two bone substitutes (allograft and bioactive glass, BonAlive®) in treating bone cysts in children (18 years or younger). The trial is carried out in five University Hospitals (Turku, Helsinki, Tampere, Oulu, Kuopio) in Finland.

Twenty patients will be randomized into each group. In all University Hospitals the treatment protocol will be same. Randomization will be performed using a sealed envelope technique.

Before surgery all patients will be examined clinically. After conventional radiographs all patients will be examined with magnetic resonance imaging showing cyst's size, anatomy, location and adjacent structures.

If the aneurysmal bone cyst is large or in difficult location, embolization by the radiologist can be used preoperatively.

Surgical technique:

Surgery will be done by experienced paediatric orthopaedic surgeons. Normal orthopaedic exposures will be used. The cyst is opened so that square window is done to the cortex. A sample to the pathologist is collected, also intraoperative frozen section is used to confirm the diagnosis. A mechanical curettage with use of a curette and a high speed burr is used to inspect the whole cavity. The tumour is resected as thoroughly as possible. After curettage 5% phenol is inserted to the cavity and it is neutralized with saline. Cyst volume is evaluated using saline (ml). Then the cyst is filled with morsellized femoral head allograft or bioactive glass (BG-S53P4) according to randomization. The biggest granule size 2-3,15mm is used for femur, tibia, pelvis and humerus. If the cyst volume is below 10ml in these places then smaller granule size (1-2mm) is chosen. If the cyst is in hand region then the granule size is 0,5-0,8mm. At the end of the operation the window's roof is inserted back. All the time X-ray is used to ensure that the whole cyst is treated properly. Osteosynthesis will be performed whenever it is necessary to prevent a pathological fracture.

After surgery the diagnosis will be confirmed histopathologically.

All patients will receive standard anesthesia.

Postoperatively an X-ray will be taken. Radiographic controls after surgery will be held at 1 Mo, 3 Mo, 6Mo, 12Mo and 24Mo. Three months control and two years control will be accompanied with MRI.

If the cyst is found after a pathologic fracture, the fracture is healed first with the cast +/- traction and MRI will be taken before surgery.

Bioactive Glass or Allogenic Bone in Pediatric Bone Cysts

A Randomized Clinical Trial Comparing Curettage With Allogenic Bone Grafting and Curettage With Bioactive Glass Filling in Children With Bone Cysts CYSTS

Enneking's grading system (scale 1-3, 1=latent, 2=active, 3=aggressive)

Musculoskeletal society tumor score (scale 0-5, 5=best outcome, 0=worst outcome)

Fracture after operation at the filled area in radiograph (yes / no)

Bonalive Biomaterials Ltd

Stratum I: comparison of three interventions (autograft, bioactive glass and beta-tricalcium phosphate)

Stratum II: comparison of three interventions (bioactive glass, beta-tricalcium phosphate, allograft)

Beta-tricalcium phosphate (ChronOs)

Surgical transplantation from iliac crest

Autograft

Allograft (frozen femoral head)

This study is designed to perform a head-to-head comparison of two synthetic ceramic bone graft substitutes, bioactive glass (BAG) and beta-tricalcium phosphate (TCP), in filling of contained bone defects following surgical evacuation of benign bone tumor or tumor-like conditions. Based on the investigators' previous preclinical research and an ongoing single-center randomized clinical trial on bioactive glass filling, the investigators expect BAG filling to be more efficient compared to TCP in promotion of defect healing and functional recovery after surgery.

This study is designed to perform a head-to-head comparison of two synthetic ceramic bone graft substitutes, bioactive glass (BAG) and beta-tricalcium phosphate (TCP), in filling of contained bone defects following surgical evacuation of benign bone tumor or tumor-like conditions. Small metacarpal and phalangeal enchondromas (Stratum I) and large long-bone lesions (Stratum II) will be evaluated separately. Aside with the head-to-head comparison of the two synthetic bone graft substitutes, autologous bone graft (Stratum I) and allogeneic bone graft (Stratum II) will be used as the standard of care controls.

Comparison of Bioactive Glass and Beta-Tricalcium Phosphate as Bone Graft Substitute

A National, Prospective, Randomized, Multicenter, Controlled Head-to-Head Comparison of Bioactive Glass and Beta-Tricalcium Phosphate as Bone Graft Substitute in Filling of Contained Bone Defects

Hand and finger grip strength measured by a standard device

Radiographic evaluation of bioactive glass and bone graft incorporation

Clinical evaluation of surgical wound healing

Clinical evaluation of soft tissue complications in the surgical area

Clinical and radiographic evaluation of complications of bone defect healing

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Bioactive Glass Granules in Filling of Bone Defects	NCT01304121	Bone Tumors	Bioactive glass...	18 Years -	Turku University Hospital
Bioactive Glass or Allogenic Bone in Pediatric Bone Cysts	NCT04737590	Bone Cysts	Bioactive glass	1 Year - 18 Years	Turku University Hospital
Bioactive Glass or Allogenic Bone in Pediatric Bone Cysts	NCT04737590	Bone Cysts	Bioactive glass	1 Year - 18 Years	Turku University Hospital
Comparison of Bioactive Glass and Beta-Tricalcium Phosphate as Bone Graft Substitute	NCT00841152	Bone Neoplasm	Bioactive glass Beta-tricalcium... Autograft Allograft (froz...	18 Years -	Turku University Hospital

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