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Massive Implants the Next Generation (MING)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03905174
Recruitment Status : Recruiting
First Posted : April 5, 2019
Last Update Posted : March 10, 2021
Sponsor:
Collaborator:
Adler Ortho
Information provided by (Responsible Party):
Iva Hauptmannova, Royal National Orthopaedic Hospital NHS Trust

Study Description
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Brief Summary:
The study will review the use of massive segmental replacements in the femur, which have a porous collar with and without HA, and autologous stem cell augment. This is a randomised controlled trial.

Condition or disease Intervention/treatment Phase
Bone Cancer Bone Diseases Device: custom made device Not Applicable

Detailed Description:

The current surgical treatment of bone cancer patients and revision limb salvage 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

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Randomised, Single Blind Study Assessing Radiological Outcomes for Massive Segmental Femoral Replacements Using Either Porous Collar or Porous Collar With HA or Porous Collar With HA and Autologous Stem Cells
Actual Study Start Date : January 20, 2019
Estimated Primary Completion Date : October 31, 2022
Estimated Study Completion Date : October 31, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Standard treatment
A porous collar for either distal or proximal femoral replacements
 Device: custom made device
surgical intervention to place custom made orthopaedic device
Other Name: custom orthopaedic implantable device
Active Comparator: standard treatment + HA
A porous collar with hydroxyapatite (HA) for either distal or proximal femoral replacements
 Device: custom made device
surgical intervention to place custom made orthopaedic device
Other Name: custom orthopaedic implantable device
Active Comparator: standard treatment + HA + autogenic cells
A porous collar with hydroxyapatite (HA) and stem cells for either distal or proximal femoral replacements
 Device: custom made device
surgical intervention to place custom made orthopaedic device
Other Name: custom orthopaedic implantable device


Outcome Measures
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Primary Outcome Measures :
  1. Radiological outcomes (X-ray, CT) [ Time Frame: at 26 weeks (+/- 2 weeks) ]
    radiological outcomes to determine integration of implant into bone - bone growth

  2. Radiological outcomes (X-ray, CT) [ Time Frame: at 1 year (+/- 2 weeks) ]
    radiological outcomes to determine integration of implant into bone - bone growth

  3. Radiological outcomes (X-ray, CT) [ Time Frame: at 2 years (+/- 2 weeks) ]
    radiological outcomes to determine integration of implant into bone - bone growth


Secondary Outcome Measures :
  1. Visual Analogue Score (VAS) pain score [ Time Frame: up to 2 years (+/- 2 weeks) ]
    visual analogue pain score to determine improvement of pain over time, 0 to 10 scale will be used (0 = no pain, higher the number the worse the pain)


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (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 and non-cancer patients requiring revision femoral segment replacement for aseptic loosening
  • Male or female, aged 18 years or above
  • Able to provide consent

Exclusion Criteria:

  • unable/unwilling to consent
  • revisions surgery due to infection
  • bone cancer patients excluded from stem cell arm
  • bone cancer patients with pathological fractures
Contacts and Locations
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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): NCT03905174


Contacts
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Contact: Panos Gikas, PhD FRCS 02089092300 rnoh.research@nhs.net
Contact: Esther Hanison, BSc 02089092300 rnoh.research@nhs.net

Locations
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United Kingdom
Royal National Orthopaedic Hospital NHS Trust Recruiting
London, Middx, United Kingdom, HA7 4LP
Contact: Esther Hanison, BSc    2089542300    rnoh.research@nhs.net   
Principal Investigator: Panos Gikas, PhD FRCS         
Sponsors and Collaborators
Iva Hauptmannova
Adler Ortho
Investigators
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Principal Investigator: Panos Gikas, PhD FRCS Royal National Orthopaedic Hospital NHS Trust
More Information
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Responsible Party: Iva Hauptmannova, Head of Research & Innovation, Royal National Orthopaedic Hospital NHS Trust
ClinicalTrials.gov Identifier: NCT03905174    
Other Study ID Numbers: 2017/MING
First Posted: April 5, 2019    Key Record Dates
Last Update Posted: March 10, 2021
Last Verified: March 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Iva Hauptmannova, Royal National Orthopaedic Hospital NHS Trust:
revision surgery
Additional relevant MeSH terms:
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Bone Neoplasms
Bone Diseases
Musculoskeletal Diseases
Neoplasms by Site
Neoplasms