Massive Implants the Next Generation (MING)

Iva Hauptmannova

Status: Enrolling

Conditions: Bone Diseases; Bone Cancer

Treatments: Device: custom made device

Study type: Interventional

Funder types: Other

Identifiers

NCT03905174

2017/MING

Details and patient eligibility

About

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.

Full 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

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 3 patient groups

Standard treatment

Active Comparator group

Description:

A porous collar for either distal or proximal femoral replacements

Treatment:

Device: custom made device

standard treatment + HA

Active Comparator group

Description:

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

Treatment:

Device: custom made device

standard treatment + HA + autogenic cells

Active Comparator group

Description:

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

Treatment:

Device: custom made device