Bone CancerMINGNCT03905174
Massive Implants the Next Generation
A study testing custom made device in people with Bone Cancer and Bone Diseases, run by Iva Hauptmannova at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bone Cancer, Bone Diseases
- What is being tested?
- custom made device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 20 Sep 2018to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- unable/unwilling to consent
- revisions surgery due to infection
- bone cancer patients excluded from stem cell arm
- bone cancer patients with pathological fractures
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Royal National Orthopaedic Hospital NHS Trust
London, Middx, HA7 4LP
Esther Hanison, BSc, 2089542300, rnoh.research@nhs.net
Panos Gikas, PhD FRCS
About this study
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
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.
Read the 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
- Conditions
- Bone Cancer, Bone Diseases
- Being tested
- custom made device
- Keywords
- revision surgery
- Medical subject headings
- Bone Neoplasms, Bone Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
custom made deviceDevice
Also called custom orthopaedic implantable device
surgical intervention to place custom made orthopaedic device
| Study group | Role | What they receive |
|---|---|---|
| Standard treatment | Active comparator | A porous collar for either distal or proximal femoral replacements Receives: Device: custom made device |
| standard treatment + HA | Active comparator | A porous collar with hydroxyapatite (HA) for either distal or proximal femoral replacements Receives: Device: custom made device |
| standard treatment + HA + autogenic cells | Active comparator | A porous collar with hydroxyapatite (HA) and stem cells for either distal or proximal femoral replacements Receives: Device: custom made device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiological outcomes (X-ray, CT)
radiological outcomes to determine integration of implant into bone - bone growth
Measured: at 26 weeks (+/- 2 weeks)
Radiological outcomes (X-ray, CT)
radiological outcomes to determine integration of implant into bone - bone growth
Measured: at 1 year (+/- 2 weeks)
Radiological outcomes (X-ray, CT)
radiological outcomes to determine integration of implant into bone - bone growth
Measured: at 2 years (+/- 2 weeks)
Secondary outcomes (1)
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)
Measured: up to 2 years (+/- 2 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2019
- Study start20 Sep 2018
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Iva Hauptmannova
- Sponsor type
- University, hospital or other
- Collaborators
- Adler Ortho
- Responsible party
- Sponsor-investigator, Iva Hauptmannova, Royal National Orthopaedic Hospital NHS Trust
- Investigators
- Panos Gikas, PhD FRCS, Principal investigator, Royal National Orthopaedic Hospital NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03905174
- Sponsor's protocol ID
- 2017/MING
- Acronym
- MING
- Status last verified
- Jun 2022
- First submitted
- 30 Jan 2019
- Last updated
- 7 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03905174
- Acronym / sponsor ID
- MING / 2017/MING
- Conditions
- Bone Cancer, Bone Diseases
- Keywords
- revision surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Iva HauptmannovaUniversity, hospital or other
- Collaborators
- Adler Ortho
- Study start
- 20 Sep 2018 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 5 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard treatment | Active comparator | Device: custom made deviceA porous collar for either distal or proximal femoral replacements |
| standard treatment + HA | Active comparator | Device: custom made deviceA porous collar with hydroxyapatite (HA) for either distal or proximal femoral replacements |
| standard treatment + HA + autogenic cells | Active comparator | Device: custom made deviceA porous collar with hydroxyapatite (HA) and stem cells for either distal or proximal femoral replacements |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- unable/unwilling to consent
- revisions surgery due to infection
- bone cancer patients excluded from stem cell arm
- bone cancer patients with pathological fractures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| custom made deviceAlso: custom orthopaedic implantable devicesurgical intervention to place custom made orthopaedic device | Device | Standard treatment, standard treatment + HA, standard treatment + HA + autogenic cells |
Primary outcome
Radiological outcomes (X-ray, CT)
Time frame: at 26 weeks (+/- 2 weeks)
radiological outcomes to determine integration of implant into bone - bone growth
Radiological outcomes (X-ray, CT)
Time frame: at 1 year (+/- 2 weeks)
radiological outcomes to determine integration of implant into bone - bone growth
Radiological outcomes (X-ray, CT)
Time frame: at 2 years (+/- 2 weeks)
radiological outcomes to determine integration of implant into bone - bone growth
1 secondary outcome
Visual Analogue Score (VAS) pain score
Time frame: up to 2 years (+/- 2 weeks)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Panos Gikas, PhD FRCS principal investigator
Royal National Orthopaedic Hospital NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing custom made device in people with Bone Cancer and Bone Diseases, run by Iva Hauptmannova at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Panos Gikas, PhD FRCS (02089092300, rnoh.research@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiological outcomes (X-ray, CT) (time frame: at 26 weeks (+/- 2 weeks)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2022.