Massive Implants the Next Generation

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03905174

Acronym

MING

Enrollment

Registered

2019-04-05

Start date

2018-09-20

Completion date

2024-12-31

Last updated

2022-06-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bone Cancer, Bone Diseases

Keywords

revision surgery

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

Interventions

DEVICEcustom made device

surgical intervention to place custom made orthopaedic device

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Radiological outcomes (X-ray, CT)	at 26 weeks (+/- 2 weeks)	radiological outcomes to determine integration of implant into bone - bone growth

Secondary

Measure	Time frame	Description
Visual Analogue Score (VAS) pain score	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)

Countries

United Kingdom

Contacts

Primary ContactPanos Gikas, PhD FRCS

rnoh.research@nhs.net02089092300

Backup ContactEsther Hanison, BSc