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Trial record 38 of 4293 for:    bone tumors AND NOT metastatic

Megaprosthetic Implants the Next Generation (MING) (MING)

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ClinicalTrials.gov Identifier: NCT03780036
Recruitment Status : Not yet recruiting
First Posted : December 19, 2018
Last Update Posted : December 19, 2018
Sponsor:
Collaborator:
Adler Ortho, iEthos Medical Ltd
Information provided by (Responsible Party):
Tel-Aviv Sourasky Medical Center

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.

Condition or disease Intervention/treatment Phase
Bone Neoplasm of Hip (Diagnosis) Device: Megaprosthetic Implants the Next Generation (MING) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Random assignment of patients into one of the two study arms: porous collar magaprostheses or porous collar with HA megaprostheses.
Masking: Single (Participant)
Masking Description: The participant will not know which implant was used for segmental replacement of his or hear femur.
Primary Purpose: Treatment
Official Title: A Randomised, Single Blind Study Assessing Radiological Outcomes for Massive Segmental Femoral Replacements Using Either Porous Collar or Porous Collar With HA
Estimated Study Start Date : February 1, 2019
Estimated Primary Completion Date : August 1, 2022
Estimated Study Completion Date : August 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bone Cancer

Arm Intervention/treatment
Experimental: porous collar
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.
Device: Megaprosthetic Implants the Next Generation (MING)
Use of either porous of porous+hydroxyapathite collars.
Other Name: Segmental bone replacement

Experimental: porous collar with hydroxyapathite
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.
Device: Megaprosthetic Implants the Next Generation (MING)
Use of either porous of porous+hydroxyapathite collars.
Other Name: Segmental bone replacement




Primary Outcome Measures :
  1. Bone incorporation [ Time Frame: 24 months ]
    Radiographic evidence of bony growth into the collar


Secondary Outcome Measures :
  1. Functional outcome - Visual Analogue Pain Scale [ Time Frame: 24 months ]
    Reporting of pain levels (from 1 to 10)

  2. Functional outcome - a physical functioning score [ Time Frame: 24 months ]
    Toronto Extremity Salvage Score (TESS) for lower extremity



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03780036


Contacts
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Contact: Haggai Schermann, MD, MPH 528771014 ext 972 sheralmi@bu.edu
Contact: Solomon Dadia, MD dadias@tlvmc.gov.il

Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
Adler Ortho, iEthos Medical Ltd

Publications:
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Responsible Party: Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier: NCT03780036     History of Changes
Other Study ID Numbers: 0619-18-TLV
First Posted: December 19, 2018    Key Record Dates
Last Update Posted: December 19, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: De-identified data will be analyzed, and its summary will be shared with other researchers.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Bone Neoplasms
Neoplasms by Site
Neoplasms
Bone Diseases
Musculoskeletal Diseases