Neoplasms

Musculoskeletal Diseases

All Conditions

Bone Neoplasms

Bone Diseases

Patients with neoplasm of femur bone who require segmental bone resection and replasement with a large prosthesis would receive an implant which collar (a circular part that comes into direct contact with the remaining bone) will be porous, to allow for bone ingrowth and stabilization of the implant.

Patients with neoplasm of femur bone who require segmental bone resection and replasement with a large prosthesis would receive an implant which collar (a circular part that comes into direct contact with the remaining bone) will be porous and covered with hydroxyapathite particles, to allow for bone ingrowth and stabilization of the implant.

Use of either porous of porous+hydroxyapathite collars.

Megaprosthetic Implants the Next Generation (MING)

Haggai Schermann, MD, MPH

Solomon Dadia, MD

This is an interventional randomized controlled trial that will compare patients who underwent segmental hip replacement using mega-implants with either porous collar or porous collar with HA. Patient recruitment will continue for 18 months. Parameters to be investigated are radiographic measures of bone incorporation into the implants, as well as patient functional outcomes. Clinical follow-up will last for 24 months for each patient.

BACKGROUND The current surgical treatment of bone cancer patients requires usage of massive endoprosthetic bone implants. The incidence of aseptic loosening is a major cause of prosthesis failure in these patients. Exploring ways to reduce such failures would allow extending longevity of massive implants in a relatively young population.

Current published literature stipulates that osteointegration could improve longevity of massive implants. Evidence suggests that usage of osteointegrated hydroxyapatite (HA) coated collar would reduce the incidence of aseptic loosening around the cemented intramedullary stem in distal femoral bone prosthesis.

Our study aims to compare radiological outcome in 2 groups:

* A porous collar for either distal or proximal femoral replacements
* A porous collar with hydroxyapatite (HA) for either distal or proximal femoral replacements The porous collar will be manufactured by Adler Ortho using additive layer manufacturing technology.

STUDY OBJECTIVES The study will review the use of massive segmental replacements in the femur, which have a porous collar with and without HA.

Primary objectives:

The primary objective of the study will be to assess radiological outcome by assessing bony growth into the collar.

Secondary objectives The secondary objective will focus on assessing patient reported outcome measures (VAS pain score and other PROMS)

STUDY DESIGN

Patients will be identified in the outpatient setting as suitable for entry into the trial based on the inclusion and exclusion criteria as set out below.

Patients will be randomised into one of the two groups of the study, due to the nature of intervention this will be a single blind study.

Patients will undergo plain radiographs immediately post-operatively, at 6 months post-operatively, 12 months post-operatively and 24 months post-operatively. Standard protocol radiographs of the relevant limb will be taken in the antero-posterior (AP) and medial-lateral (ML) planes (x2 AP and x2 laterals to cover the prosthesis).

At 12 months and 24 months post-operatively patients will receive a CT scan (cover whole prosthesis, extended CT - knee, pelvis), which will be used to image bone growth within the porous collars.

For plain radiographs a scoring system for extra-cortical bone formation will be made according to Coathup et al, 2013. This will be quantified radiologically in four zones (medial and lateral aspects on AP radiographs; anterior and posterior aspects on ML radiographs). Extracortical bone separated from the implant by a clear radiolucent line is not considered in grown and will be scored 0. A score of 1 will represent extracortical bone (\>5mm think and \>1mm long) in contact with the implant surface in any of the four previously described zones. The maximum score will be 4, denoting extracortical bone growth in all four zones.

Patients identified and consented in clinic for entry into study. Randomisation prior to surgical date. Baseline X-ray and CT done pre-operatively as per current pre-operative guidelines.

Pre-operative bloods and joint aspiration done to definitively rule out infection in revision patients Pre-operative VAS pain score on admission

Joint replacement done - clarify antibiotic prophylaxis with surgeons - induction + extended post-operative antibiotic prophylaxis

Post-operative Toronto Extremity Salvage Score (TESS) to assess physical functioning for all patients. TESS repeated at 6, 12 and 24 months to assess progress post-operatively - correlating with radiographical findings.

Surgery related data including theatre time, intra-operative blood loss and intra- and post-operative complications will be recorded for all patients.

Immediate post-operative, 6, 12 and 24 monthly X-rays (x2 AP and x2 laterals to cover the prosthesis); 12 and 24 monthly CT (cover whole prosthesis, extended CT - knee, pelvis) X-rays and CT reported by scores calculated as previously described.

Random assignment of patients into one of the two study arms: porous collar magaprostheses or porous collar with HA megaprostheses.

The participant will not know which implant was used for segmental replacement of his or hear femur.

A Randomised, Single Blind Study Assessing Radiological Outcomes for Massive Segmental Femoral Replacements Using Either Porous Collar or Porous Collar With HA

De-identified data will be analyzed, and its summary will be shared with other researchers.

Radiographic evidence of bony growth into the collar

Toronto Extremity Salvage Score (TESS) for lower extremity

Adler Ortho, iEthos Medical Ltd

Tel-Aviv Sourasky Medical Center

Wounds and Injuries

Symptoms and General Pathology

Diseases and Abnormalities at or Before Birth

Fractures, Bone

Neoplasm Metastasis

Congenital Abnormalities

Neoplastic Processes

Decision on preventive surgery vs follow-up will be based on expert judgement, Mirels' score and CTFEA

Decision on preventive surgery vs follow-up will be based on expert judgement and Mirels' score

CT scans are used to generate a finite element model of patient-specific long bones. The bone model is loaded in stance position. Load based on patient's weight and the mechanical response, including the risk of fracture, is computed.

CTFEA

Decision on surgery vs follow-up will be based on expert opinion and Mirels' score

Conventional decision algorithm

Haggai Schermann, MD

Amir Sternheim, MD

Patients with metastases to proximal femur, who are evaluated fr the risk of pathologic fracture in order to decide on preventive fixation vs follow-up constitute the study population. The patients will be randomized in two arms. First arm - the decision of treatment will rely on conventional decision algorithm including specialist judgement and Mirels' score. Second arm- the decision on treatment will be supported by CTFEA analysis of bone structure and quantitative simulation-based estimate of fracture risk, in addition to the conventional decision algorithm. Operation rates, pathologic fracture rates and additional secondary outcomes will be compared between the two study arms.

Patients will be randomized to two arms and followed prospectively

Evaluation of the Ability of CT-based Finite Element Analysis (CTFEA) to Predict Fractures in Patients With Metastases: a Randomized Controlled Study.

The individual participant data will remain in TLVMC and will not be shared

Number of patients who became unable to ambulate for any reason. Inability to ambulate will be determined by an orthopedic surgeon from anamnesis and physical examination.

Number of participants who sustained a pathological fracture. Diagnosis of pathological fracture will be determined by an orthopedic surgeon based on imaging.

Death within 30 days after prophylactic surgery

Infection, re-operation, mechanical failure within 4 months of follow up

The number of surgeries "avoided" - presented only in the group of Intervention and only in patients without the safety endpoint within 4 months of follow up. Specifically, number of patients without the safety endpoint in whom a physician changed his/her decision to operate based on the CT-based FE analysis.

Agreement between the pathological fracture risk estimated using Mirels' scale and the pathological fracture risk CT-based FE simulation analysis. Risk levels determined by either of the estimates: low, medium, high

Number of patients who did not undergo a prophylactic surgery, in whom the CT-based FE analysis showed a risk above moderate for fractures in future and who developed a fracture during the 4 months of follow-up - calculated in both study groups.

Number of patients who underwent a prophylactic surgery, in whom the CT-based FE analysis showed a mild-moderate risk of a fracture and who devel-oped a complication (as defined in a composite safety endpoint) - calculated in both study groups

To compare proportion of patients undergoing surgery in the treatment group vs the control group.

pathological fracture during 4 months of follow up OR death within 30 days after prophylactic surgery in patients who underwent surgery OR surgical complications within 4 months of follow up: infection, re-operation, mechanical failure

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Megaprosthetic Implants the Next Generation (MING)	NCT03780036	Bone Neoplasm o...	Megaprosthetic ...	18 Years - 80 Years	Tel-Aviv Sourasky Medical Center
Megaprosthetic Implants the Next Generation (MING)	NCT03780036	Bone Neoplasm o...	Megaprosthetic ...	18 Years - 80 Years	Tel-Aviv Sourasky Medical Center
Evaluation of the Ability of CT-based Finite Element Analysis (CTFEA) to Predict Fractures in Patients With Metastases: a Randomized Controlled Study.	NCT03453905	Bone Neoplasm o... Orthopedic Diso... Bone Metastases Proximal Femora...	CTFEA Conventional de...	18 Years - 120 Years	Tel-Aviv Sourasky Medical Center

Spots Global Cancer Trial Database for bone neoplasm of hip (diagnosis)