- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03780036
Megaprosthetic Implants the Next Generation (MING) (MING)
A Randomised, Single Blind Study Assessing Radiological Outcomes for Massive Segmental Femoral Replacements Using Either Porous Collar or Porous Collar With HA
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
BACKGROUND The current surgical treatment of bone cancer patients 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.
Our study aims to compare radiological outcome in 2 groups:
- A porous collar for either distal or proximal femoral replacements
- A porous collar with hydroxyapatite (HA) for either distal or proximal femoral replacements The porous collar will be manufactured by Adler Ortho using additive layer manufacturing technology.
STUDY OBJECTIVES The study will review the use of massive segmental replacements in the femur, which have a porous collar with and without HA.
Primary objectives:
The primary objective of the study will be to assess radiological outcome by assessing bony growth into the collar.
Secondary objectives The secondary objective will focus on assessing patient reported outcome measures (VAS pain score and other PROMS)
STUDY DESIGN
Patients will be identified in the outpatient setting as suitable for entry into the trial based on the inclusion and exclusion criteria as set out below.
Patients will be randomised into one of the two groups of the study, due to the nature of intervention this will be a single blind study.
Patients will undergo plain radiographs immediately post-operatively, at 6 months post-operatively, 12 months post-operatively and 24 months post-operatively. Standard protocol radiographs of the relevant limb will be taken in the antero-posterior (AP) and medial-lateral (ML) planes (x2 AP and x2 laterals to cover the prosthesis).
At 12 months and 24 months post-operatively patients will receive a CT scan (cover whole prosthesis, extended CT - knee, pelvis), which will be used to image bone growth within the porous collars.
For plain radiographs a scoring system for extra-cortical bone formation will be made according to Coathup et al, 2013. This will be quantified radiologically in four zones (medial and lateral aspects on AP radiographs; anterior and posterior aspects on ML radiographs). Extracortical bone separated from the implant by a clear radiolucent line is not considered in grown and will be scored 0. A score of 1 will represent extracortical bone (>5mm think and >1mm long) in contact with the implant surface in any of the four previously described zones. The maximum score will be 4, denoting extracortical bone growth in all four zones.
Patients identified and consented in clinic for entry into study. Randomisation prior to surgical date. Baseline X-ray and CT done pre-operatively as per current pre-operative guidelines.
Pre-operative bloods and joint aspiration done to definitively rule out infection in revision patients Pre-operative VAS pain score on admission
Joint replacement done - clarify antibiotic prophylaxis with surgeons - induction + extended post-operative antibiotic prophylaxis
Post-operative Toronto Extremity Salvage Score (TESS) to assess physical functioning for all patients. TESS repeated at 6, 12 and 24 months to assess progress post-operatively - correlating with radiographical findings.
Surgery related data including theatre time, intra-operative blood loss and intra- and post-operative complications will be recorded for all patients.
Immediate post-operative, 6, 12 and 24 monthly X-rays (x2 AP and x2 laterals to cover the prosthesis); 12 and 24 monthly CT (cover whole prosthesis, extended CT - knee, pelvis) X-rays and CT reported by scores calculated as previously described.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Haggai Schermann, MD, MPH
- Phone Number: 972 528771014
- Email: sheralmi@bu.edu
Study Contact Backup
- Name: Solomon Dadia, MD
- Email: dadias@tlvmc.gov.il
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Bone cancer patients requiring primary or revision femoral segmental replacements (excluding infections) and non-cancer patients requiring revision femoral segment replacement for aseptic loosening (excluding infections)
- Male or female, aged 18-80 years
- Participants willing and able to give informed consent for participation in the study
Exclusion Criteria:
- Participants unwilling or unable to give informed consent for participation in the study
- Patients undergoing revision due to infection, identified by positive growth from joint aspiration OR elevated pre-operative inflammatory markers OR radiographical evidence of prosthetic joint infection
- Bone cancer patients presenting with pathological fractures requiring segmental femoral replacement
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: porous collar
Patients with neoplasm of femur bone who require segmental bone resection and replasement with a large prosthesis would receive an implant which collar (a circular part that comes into direct contact with the remaining bone) will be porous, to allow for bone ingrowth and stabilization of the implant.
|
Use of either porous of porous+hydroxyapathite collars.
Other Names:
|
EXPERIMENTAL: porous collar with hydroxyapathite
Patients with neoplasm of femur bone who require segmental bone resection and replasement with a large prosthesis would receive an implant which collar (a circular part that comes into direct contact with the remaining bone) will be porous and covered with hydroxyapathite particles, to allow for bone ingrowth and stabilization of the implant.
|
Use of either porous of porous+hydroxyapathite collars.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Bone incorporation
Time Frame: 24 months
|
Radiographic evidence of bony growth into the collar
|
24 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Functional outcome - Visual Analogue Pain Scale
Time Frame: 24 months
|
Reporting of pain levels (from 1 to 10)
|
24 months
|
Functional outcome - a physical functioning score
Time Frame: 24 months
|
Toronto Extremity Salvage Score (TESS) for lower extremity
|
24 months
|
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
General Publications
- Coathup MJ, Sanghrajka A, Aston WJ, Gikas PD, Pollock RC, Cannon SR, Skinner JA, Briggs TW, Blunn GW. Hydroxyapatite-coated collars reduce radiolucent line progression in cemented distal femoral bone tumor implants. Clin Orthop Relat Res. 2015 Apr;473(4):1505-14. doi: 10.1007/s11999-014-4116-6. Epub 2015 Jan 30.
- Coathup MJ, Batta V, Pollock RC, Aston WJ, Cannon SR, Skinner JA, Briggs TW, Unwin PS, Blunn GW. Long-term survival of cemented distal femoral endoprostheses with a hydroxyapatite-coated collar: a histological study and a radiographic follow-up. J Bone Joint Surg Am. 2013 Sep 4;95(17):1569-75. doi: 10.2106/JBJS.L.00362.
- Mumith A, Coathup M, Chimutengwende-Gordon M, Aston W, Briggs T, Blunn G. Augmenting the osseointegration of endoprostheses using laser-sintered porous collars: an in vivo study. Bone Joint J. 2017 Feb;99-B(2):276-282. doi: 10.1302/0301-620X.99B2.BJJ-2016-0584.R1.
Study record dates
Study Major Dates
Study Start (ANTICIPATED)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0619-18-TLV
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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