Massive Implants the Next Generation

Bone Diseases Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03905174
• Other study ID #: 2017/MING
• Status: Recruiting
• Phase: N/A
• Start date: September 20, 2018
• Est. completion date: December 31, 2024

Study information

• Verified date: June 2022
• Source: Royal National Orthopaedic Hospital NHS Trust
• Contact: Panos Gikas, PhD FRCS
• Phone: 02089092300
• Email: rnoh.research[@]nhs.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bone Cancer
• Bone Diseases
• Bone Neoplasms

Intervention

Device:
• custom made device
surgical intervention to place custom made orthopaedic device

Locations

Country	Name	City	State
United Kingdom	Royal National Orthopaedic Hospital NHS Trust	London	Middx

Sponsors (2)

Lead Sponsor	Collaborator
Iva Hauptmannova	Adler Ortho

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Radiological outcomes (X-ray, CT)	radiological outcomes to determine integration of implant into bone - bone growth	at 26 weeks (+/- 2 weeks)
Primary	Radiological outcomes (X-ray, CT)	radiological outcomes to determine integration of implant into bone - bone growth	at 1 year (+/- 2 weeks)
Primary	Radiological outcomes (X-ray, CT)	radiological outcomes to determine integration of implant into bone - bone growth	at 2 years (+/- 2 weeks)
Secondary	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)	up to 2 years (+/- 2 weeks)