Massive Implants the Next Generation
MING
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
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2018
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 20, 2018
CompletedFirst Submitted
Initial submission to the registry
January 30, 2019
CompletedFirst Posted
Study publicly available on registry
April 5, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2024
CompletedJune 7, 2022
June 1, 2022
6.3 years
January 30, 2019
June 6, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Radiological outcomes (X-ray, CT)
radiological outcomes to determine integration of implant into bone - bone growth
at 26 weeks (+/- 2 weeks)
Radiological outcomes (X-ray, CT)
radiological outcomes to determine integration of implant into bone - bone growth
at 1 year (+/- 2 weeks)
Radiological outcomes (X-ray, CT)
radiological outcomes to determine integration of implant into bone - bone growth
at 2 years (+/- 2 weeks)
Secondary Outcomes (1)
Visual Analogue Score (VAS) pain score
up to 2 years (+/- 2 weeks)
Study Arms (3)
Standard treatment
ACTIVE COMPARATORA porous collar for either distal or proximal femoral replacements
standard treatment + HA
ACTIVE COMPARATORA porous collar with hydroxyapatite (HA) for either distal or proximal femoral replacements
standard treatment + HA + autogenic cells
ACTIVE COMPARATORA porous collar with hydroxyapatite (HA) and stem cells for either distal or proximal femoral replacements
Interventions
surgical intervention to place custom made orthopaedic device
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- unable/unwilling to consent
- revisions surgery due to infection
- bone cancer patients excluded from stem cell arm
- bone cancer patients with pathological fractures
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Iva Hauptmannovalead
- Adler Orthocollaborator
Study Sites (1)
Royal National Orthopaedic Hospital NHS Trust
London, Middx, HA7 4LP, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Panos Gikas, PhD FRCS
Royal National Orthopaedic Hospital NHS Trust
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Head of Research & Innovation
Study Record Dates
First Submitted
January 30, 2019
First Posted
April 5, 2019
Study Start
September 20, 2018
Primary Completion
December 31, 2024
Study Completion
December 31, 2024
Last Updated
June 7, 2022
Record last verified: 2022-06