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Massive Implants the Next Generation (MING)

Primary Purpose

Bone Cancer, Bone Diseases

Status
Recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
custom made device
Sponsored by
Iva Hauptmannova
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Bone Cancer focused on measuring revision surgery

Eligibility Criteria

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

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

Sites / Locations

  • Royal National Orthopaedic Hospital NHS TrustRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Standard treatment

standard treatment + HA

standard treatment + HA + autogenic cells

Arm Description

A porous collar for either distal or proximal femoral replacements

A porous collar with hydroxyapatite (HA) for either distal or proximal femoral replacements

A porous collar with hydroxyapatite (HA) and stem cells for either distal or proximal femoral replacements

Outcomes

Primary Outcome Measures

Radiological outcomes (X-ray, CT)
radiological outcomes to determine integration of implant into bone - bone growth
Radiological outcomes (X-ray, CT)
radiological outcomes to determine integration of implant into bone - bone growth
Radiological outcomes (X-ray, CT)
radiological outcomes to determine integration of implant into bone - bone growth

Secondary Outcome Measures

Visual Analogue Score (VAS) pain score
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)

Full Information

First Posted
January 30, 2019
Last Updated
June 6, 2022
Sponsor
Iva Hauptmannova
Collaborators
Adler Ortho
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1. Study Identification

Unique Protocol Identification Number
NCT03905174
Brief Title
Massive Implants the Next Generation
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 or Porous Collar With HA and Autologous Stem Cells
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 20, 2018 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Iva Hauptmannova
Collaborators
Adler Ortho

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
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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bone Cancer, Bone Diseases
Keywords
revision surgery

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard treatment
Arm Type
Active Comparator
Arm Description
A porous collar for either distal or proximal femoral replacements
Arm Title
standard treatment + HA
Arm Type
Active Comparator
Arm Description
A porous collar with hydroxyapatite (HA) for either distal or proximal femoral replacements
Arm Title
standard treatment + HA + autogenic cells
Arm Type
Active Comparator
Arm Description
A porous collar with hydroxyapatite (HA) and stem cells for either distal or proximal femoral replacements
Intervention Type
Device
Intervention Name(s)
custom made device
Other Intervention Name(s)
custom orthopaedic implantable device
Intervention Description
surgical intervention to place custom made orthopaedic device
Primary Outcome Measure Information:
Title
Radiological outcomes (X-ray, CT)
Description
radiological outcomes to determine integration of implant into bone - bone growth
Time Frame
at 26 weeks (+/- 2 weeks)
Title
Radiological outcomes (X-ray, CT)
Description
radiological outcomes to determine integration of implant into bone - bone growth
Time Frame
at 1 year (+/- 2 weeks)
Title
Radiological outcomes (X-ray, CT)
Description
radiological outcomes to determine integration of implant into bone - bone growth
Time Frame
at 2 years (+/- 2 weeks)
Secondary Outcome Measure Information:
Title
Visual Analogue Score (VAS) pain score
Description
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)
Time Frame
up to 2 years (+/- 2 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Panos Gikas, PhD FRCS
Phone
02089092300
Email
rnoh.research@nhs.net
First Name & Middle Initial & Last Name or Official Title & Degree
Esther Hanison, BSc
Phone
02089092300
Email
rnoh.research@nhs.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Panos Gikas, PhD FRCS
Organizational Affiliation
Royal National Orthopaedic Hospital NHS Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royal National Orthopaedic Hospital NHS Trust
City
London
State/Province
Middx
ZIP/Postal Code
HA7 4LP
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Esther Hanison, BSc
Phone
2089542300
Email
rnoh.research@nhs.net
First Name & Middle Initial & Last Name & Degree
Panos Gikas, PhD FRCS

12. IPD Sharing Statement

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Massive Implants the Next Generation

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