Massive Implants the Next Generation (MING)

June 6, 2022 updated by: Iva Hauptmannova

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United Kingdom
    • Middx
      • London, Middx, United Kingdom, HA7 4LP
        • Recruiting
        • Royal National Orthopaedic Hospital NHS Trust
        • Contact:
        • Principal Investigator:
          • Panos Gikas, PhD FRCS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • 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 Names:
  • custom orthopaedic implantable device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Radiological outcomes (X-ray, CT)
Time Frame: at 26 weeks (+/- 2 weeks)
radiological outcomes to determine integration of implant into bone - bone growth
at 26 weeks (+/- 2 weeks)
Radiological outcomes (X-ray, CT)
Time Frame: at 1 year (+/- 2 weeks)
radiological outcomes to determine integration of implant into bone - bone growth
at 1 year (+/- 2 weeks)
Radiological outcomes (X-ray, CT)
Time Frame: at 2 years (+/- 2 weeks)
radiological outcomes to determine integration of implant into bone - bone growth
at 2 years (+/- 2 weeks)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
up to 2 years (+/- 2 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Iva Hauptmannova

Collaborators

Adler Ortho

Investigators

  • Principal Investigator: Panos Gikas, PhD FRCS, Royal National Orthopaedic Hospital NHS Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 20, 2018

Primary Completion (Anticipated)

December 31, 2024

Study Completion (Anticipated)

December 31, 2024

Study Registration Dates

First Submitted

January 30, 2019

First Submitted That Met QC Criteria

April 3, 2019

First Posted (Actual)

April 5, 2019

Study Record Updates

Last Update Posted (Actual)

June 7, 2022

Last Update Submitted That Met QC Criteria

June 6, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017/MING

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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