Massive Implants the Next Generation

NCT ID: NCT03905174

Last Updated: 2022-06-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-20

Study Completion Date

2024-12-31

Brief Summary

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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

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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

Conditions

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Bone Cancer Bone Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Standard treatment

A porous collar for either distal or proximal femoral replacements

Group Type ACTIVE_COMPARATOR

custom made device

Intervention Type DEVICE

surgical intervention to place custom made orthopaedic device

standard treatment + HA

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

Group Type ACTIVE_COMPARATOR

custom made device

Intervention Type DEVICE

surgical intervention to place custom made orthopaedic device

standard treatment + HA + autogenic cells

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

Group Type ACTIVE_COMPARATOR

custom made device

Intervention Type DEVICE

surgical intervention to place custom made orthopaedic device

Interventions

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custom made device

surgical intervention to place custom made orthopaedic device

Intervention Type DEVICE

Other Intervention Names

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custom orthopaedic implantable device

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Adler Ortho

UNKNOWN

Sponsor Role collaborator

Iva Hauptmannova

OTHER

Sponsor Role lead

Responsible Party

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Iva Hauptmannova

Head of Research & Innovation

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Panos Gikas, PhD FRCS

Role: PRINCIPAL_INVESTIGATOR

Royal National Orthopaedic Hospital NHS Trust

Locations

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Royal National Orthopaedic Hospital NHS Trust

London, Middx, United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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Panos Gikas, PhD FRCS

Role: CONTACT

02089092300

Esther Hanison, BSc

Role: CONTACT

02089092300

Facility Contacts

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Esther Hanison, BSc

Role: primary

2089542300

Other Identifiers

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2017/MING

Identifier Type: -

Identifier Source: org_study_id

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