search
Back to results

Megaprosthetic Implants the Next Generation (MING) (MING)

Primary Purpose

Bone Neoplasm of Hip (Diagnosis)

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Megaprosthetic Implants the Next Generation (MING)
Sponsored by
Tel-Aviv Sourasky Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bone Neoplasm of Hip (Diagnosis)

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Bone cancer patients requiring primary or revision femoral segmental replacements (excluding infections) and non-cancer patients requiring revision femoral segment replacement for aseptic loosening (excluding infections)
  • Male or female, aged 18-80 years
  • Participants willing and able to give informed consent for participation in the study

Exclusion Criteria:

  • Participants unwilling or unable to give informed consent for participation in the study
  • Patients undergoing revision due to infection, identified by positive growth from joint aspiration OR elevated pre-operative inflammatory markers OR radiographical evidence of prosthetic joint infection
  • Bone cancer patients presenting with pathological fractures requiring segmental femoral replacement

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    porous collar

    porous collar with hydroxyapathite

    Arm Description

    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.

    Outcomes

    Primary Outcome Measures

    Bone incorporation
    Radiographic evidence of bony growth into the collar

    Secondary Outcome Measures

    Functional outcome - Visual Analogue Pain Scale
    Reporting of pain levels (from 1 to 10)
    Functional outcome - a physical functioning score
    Toronto Extremity Salvage Score (TESS) for lower extremity

    Full Information

    First Posted
    December 17, 2018
    Last Updated
    December 17, 2018
    Sponsor
    Tel-Aviv Sourasky Medical Center
    Collaborators
    Adler Ortho, iEthos Medical Ltd
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT03780036
    Brief Title
    Megaprosthetic Implants the Next Generation (MING)
    Acronym
    MING
    Official Title
    A Randomised, Single Blind Study Assessing Radiological Outcomes for Massive Segmental Femoral Replacements Using Either Porous Collar or Porous Collar With HA
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    February 1, 2019 (Anticipated)
    Primary Completion Date
    August 1, 2022 (Anticipated)
    Study Completion Date
    August 1, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Tel-Aviv Sourasky Medical Center
    Collaborators
    Adler Ortho, iEthos Medical Ltd

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    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.
    Detailed Description
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Bone Neoplasm of Hip (Diagnosis)

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Random assignment of patients into one of the two study arms: porous collar magaprostheses or porous collar with HA megaprostheses.
    Masking
    Participant
    Masking Description
    The participant will not know which implant was used for segmental replacement of his or hear femur.
    Allocation
    Randomized
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    porous collar
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    porous collar with hydroxyapathite
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Device
    Intervention Name(s)
    Megaprosthetic Implants the Next Generation (MING)
    Other Intervention Name(s)
    Segmental bone replacement
    Intervention Description
    Use of either porous of porous+hydroxyapathite collars.
    Primary Outcome Measure Information:
    Title
    Bone incorporation
    Description
    Radiographic evidence of bony growth into the collar
    Time Frame
    24 months
    Secondary Outcome Measure Information:
    Title
    Functional outcome - Visual Analogue Pain Scale
    Description
    Reporting of pain levels (from 1 to 10)
    Time Frame
    24 months
    Title
    Functional outcome - a physical functioning score
    Description
    Toronto Extremity Salvage Score (TESS) for lower extremity
    Time Frame
    24 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Bone cancer patients requiring primary or revision femoral segmental replacements (excluding infections) and non-cancer patients requiring revision femoral segment replacement for aseptic loosening (excluding infections) Male or female, aged 18-80 years Participants willing and able to give informed consent for participation in the study Exclusion Criteria: Participants unwilling or unable to give informed consent for participation in the study Patients undergoing revision due to infection, identified by positive growth from joint aspiration OR elevated pre-operative inflammatory markers OR radiographical evidence of prosthetic joint infection Bone cancer patients presenting with pathological fractures requiring segmental femoral replacement
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Haggai Schermann, MD, MPH
    Phone
    528771014
    Ext
    972
    Email
    sheralmi@bu.edu
    First Name & Middle Initial & Last Name or Official Title & Degree
    Solomon Dadia, MD
    Email
    dadias@tlvmc.gov.il

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    De-identified data will be analyzed, and its summary will be shared with other researchers.
    Citations:
    PubMed Identifier
    25634027
    Citation
    Coathup MJ, Sanghrajka A, Aston WJ, Gikas PD, Pollock RC, Cannon SR, Skinner JA, Briggs TW, Blunn GW. Hydroxyapatite-coated collars reduce radiolucent line progression in cemented distal femoral bone tumor implants. Clin Orthop Relat Res. 2015 Apr;473(4):1505-14. doi: 10.1007/s11999-014-4116-6. Epub 2015 Jan 30.
    Results Reference
    background
    PubMed Identifier
    24005197
    Citation
    Coathup MJ, Batta V, Pollock RC, Aston WJ, Cannon SR, Skinner JA, Briggs TW, Unwin PS, Blunn GW. Long-term survival of cemented distal femoral endoprostheses with a hydroxyapatite-coated collar: a histological study and a radiographic follow-up. J Bone Joint Surg Am. 2013 Sep 4;95(17):1569-75. doi: 10.2106/JBJS.L.00362.
    Results Reference
    background
    PubMed Identifier
    28148673
    Citation
    Mumith A, Coathup M, Chimutengwende-Gordon M, Aston W, Briggs T, Blunn G. Augmenting the osseointegration of endoprostheses using laser-sintered porous collars: an in vivo study. Bone Joint J. 2017 Feb;99-B(2):276-282. doi: 10.1302/0301-620X.99B2.BJJ-2016-0584.R1.
    Results Reference
    background

    Learn more about this trial

    Megaprosthetic Implants the Next Generation (MING)

    We'll reach out to this number within 24 hrs