Head and Neck CancerRifRamNCT05153733
Improved Implant for Reconstruction Purposes After Mandibular Resection
A study testing RIFRAM implant in people with Head and Neck Cancer and Oral Cancer, run by The Netherlands Cancer Institute at 1 site in Netherlands.
Trial summary
Study design: A single center non-randomized, prospective clinical feasibility study. Study population: Study population is composed of 10 patients ineligible for a free-flap bone reconstruction. Intervention: The selected patients will receive the newly developed, patient-specific RIfRaM mandibular implant. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Head and Neck Cancer, Oral Cancer
- What is being tested?
- RIFRAM implant
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteNetherlands
- Study dates
- 29 Nov 2021to 13 Mar 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years at time of study entry.
- T4 oral cavity tumor with mandible invasion, requiring segmental mandibulectomy.
- Reconstruction with free fibula flap not feasible because of any or a combination of the following reasons:
- oCT angiography of the legs and/or the neck shows severe stenosis of the ves-sels.
- Previous medical history of severe atherosclerotic disease.
- General health condition necessitating a shorter operation time.
- Cases will be discussed in the multidisciplinary tumor board that they are eligible for composite resection but not eligible for free fibula flap.
- Written informed consent.
Who cannot join
- Patients who are eligible for free fibula flap.
- Pregnancy.
- General health condition does not allow surgery
- History of psychiatric disability judged by the investigator to potentially hamper compliance with the study protocol and follow-up schedule.
- Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Antoni van Leeuwenhoek
Amsterdam, North Holland, 1082 MK
About this study
Study design: A single center non-randomized, prospective clinical feasibility study.
Study population: Study population is composed of 10 patients ineligible for a free-flap bone reconstruction.
Read more
Intervention: The selected patients will receive the newly developed, patient-specific RIfRaM mandibular implant.
Objective: The aim is to provide enough evidence through model analysis, physical tests and clinical study of 10 patients that our new type of personalized mandibular implant is safe to use, resulting in significantly fewer complications and can be practically placed during the surgery, without any complications.
Main study parameters/endpoints: The study endpoint is to use the RifRaM without any implant related complications and a perfect mandibular fit.
Read the detailed description
The preoperative bony resection planning and the design of the RifRam implant will be carried out on 3D reconstructed CT image of the mandible. The necessary resection planes will be marked on the 3D model. This segment will be removed virtually and replaced by the designed RifRam implant. The form of the implant will follow the contours of the native healthy mandible. In case, extensive bone destruction of the mandible does not allow copying the contours, contralateral side of the mandible will be virtually mirrored and used to design the implant. The design of the implant will be carried out within the NKI/AVL and the data will be preserved in restricted access folders. The designed implant will be printed with a hollow mesh core by Mobius. A matching cutting guide will be printed as well. Two copies of the implant will be delivered in case one would be accidentally be unsterile (see 5.3). The cutting guides are used to cut the mandible at exactly the intended places. The implant and the cutting guide will be delivered to the hospital and sterilized by Clinium for clinical use.
The patient will undergo a COMMANDO (combined mandibulectomy and neck dissection) procedure. The steps of this procedure are well defined and can be found in iProva. The oncological resection will be carried out in the standard fashion. Mandible saw cutting guides are used as standard procedure. The patient specific mandible cutting guide will be fixed on the mandible and the cuts to the mandible will be made through the cutting slots. This step enables that the mandible defect matches exactly the RifRam implant. After the resection is completed and the surgical site irrigated as per standard procedure, the Rifram implant will be placed to fill the bone defect. The implant will be fixed with 2.7 mm locking screws produced by KLS Martin. These screws are used are used as standard and are available in stock in the operation complex. The soft tissue defect will be reconstructed using a regional flap such as pectoralis major musculocutaneous flap. The rest of the procedure will be completed as per established clinical protocol.
- Conditions
- Head and Neck Cancer, Oral Cancer
- Being tested
- RIFRAM implant
- Keywords
- surgery, COMMANDO
- Medical subject headings
- Head and Neck Neoplasms, Mouth Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RIFRAM implantDevice
Also called COMMANDO
Participants will receive the newly developed, patient-specific RIfRaM mandibular implant.
| Study group | Role | What they receive |
|---|---|---|
| RIFRAM implant | Experimental | RIFRAM implant Receives: Device: RIFRAM implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical fit
good fit during surgery, suboptimal fit of the mandible making placement not possible.
Measured: intra-operative
Complications
Implant related complications leading to implant loss
Measured: implant loss in 1-year post-operational follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2021
- Study start29 Nov 2021
- Primary completion13 Mar 2024
- Study completion13 Mar 2024
Why it stopped: End point is reached with 1 implant which is removed within the observation period
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Netherlands Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Baris Karakullukcu, PhD, Principal investigator, The Netherlands Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05153733
- Sponsor's protocol ID
- N19IRM
- Other IDs
- NL74131.031.20
- Acronym
- RifRam
- Status last verified
- Jul 2024
- First submitted
- 29 Nov 2021
- Last updated
- 24 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improved Implant for Reconstruction Purposes After Mandibular Resection
- ClinicalTrials.gov ID
- NCT05153733
- Acronym / sponsor ID
- RifRam / N19IRM
- Conditions
- Head and Neck Cancer, Oral Cancer
- Keywords
- surgery, COMMANDO
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: End point is reached with 1 implant which is removed within the observation period
- Enrolment
- 3 participants (actual)
- Lead sponsor
- The Netherlands Cancer InstituteUniversity, hospital or other
- Study start
- 29 Nov 2021 (actual)
- Primary completion
- 13 Mar 2024 (actual)
- Study completion
- 13 Mar 2024 (actual)
- First posted
- 10 Dec 2021 (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.
Study design: A single center non-randomized, prospective clinical feasibility study.
Study population: Study population is composed of 10 patients ineligible for a free-flap bone reconstruction.
Intervention: The selected patients will receive the newly developed, patient-specific RIfRaM mandibular implant.
Objective: The aim is to provide enough evidence through model analysis, physical tests and clinical study of 10 patients that our new type of personalized mandibular implant is safe to use, resulting in significantly fewer complications and can be practically placed during the surgery, without any complications.
Main study parameters/endpoints: The study endpoint is to use the RifRaM without any implant related complications and a perfect mandibular fit.
Detailed description
The preoperative bony resection planning and the design of the RifRam implant will be carried out on 3D reconstructed CT image of the mandible. The necessary resection planes will be marked on the 3D model. This segment will be removed virtually and replaced by the designed RifRam implant. The form of the implant will follow the contours of the native healthy mandible. In case, extensive bone destruction of the mandible does not allow copying the contours, contralateral side of the mandible will be virtually mirrored and used to design the implant. The design of the implant will be carried out within the NKI/AVL and the data will be preserved in restricted access folders. The designed implant will be printed with a hollow mesh core by Mobius. A matching cutting guide will be printed as well. Two copies of the implant will be delivered in case one would be accidentally be unsterile (see 5.3). The cutting guides are used to cut the mandible at exactly the intended places. The implant and the cutting guide will be delivered to the hospital and sterilized by Clinium for clinical use.
The patient will undergo a COMMANDO (combined mandibulectomy and neck dissection) procedure. The steps of this procedure are well defined and can be found in iProva. The oncological resection will be carried out in the standard fashion. Mandible saw cutting guides are used as standard procedure. The patient specific mandible cutting guide will be fixed on the mandible and the cuts to the mandible will be made through the cutting slots. This step enables that the mandible defect matches exactly the RifRam implant. After the resection is completed and the surgical site irrigated as per standard procedure, the Rifram implant will be placed to fill the bone defect. The implant will be fixed with 2.7 mm locking screws produced by KLS Martin. These screws are used are used as standard and are available in stock in the operation complex. The soft tissue defect will be reconstructed using a regional flap such as pectoralis major musculocutaneous flap. The rest of the procedure will be completed as per established clinical protocol.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RIFRAM implant | Experimental | Device: RIFRAM implantRIFRAM implant |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age ≥ 18 years at time of study entry.
- T4 oral cavity tumor with mandible invasion, requiring segmental mandibulectomy.
- Reconstruction with free fibula flap not feasible because of any or a combination of the following reasons:
- oCT angiography of the legs and/or the neck shows severe stenosis of the ves-sels.
- Previous medical history of severe atherosclerotic disease.
Key exclusion criteria (5 listed)
- Patients who are eligible for free fibula flap.
- Pregnancy.
- General health condition does not allow surgery
- History of psychiatric disability judged by the investigator to potentially hamper compliance with the study protocol and follow-up schedule.
- Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.
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 |
|---|---|---|
| RIFRAM implantAlso: COMMANDOParticipants will receive the newly developed, patient-specific RIfRaM mandibular implant. | Device | RIFRAM implant |
Primary outcome
Surgical fit
Time frame: intra-operative
good fit during surgery, suboptimal fit of the mandible making placement not possible.
Complications
Time frame: implant loss in 1-year post-operational follow-up.
Implant related complications leading to implant loss
Results and safety
The study was stopped early (reason given: End point is reached with 1 implant which is removed within the observation period). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2024.
- Individual participant dataSharing planned: No
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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.
Baris Karakullukcu, PhD principal investigator
The Netherlands Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RIFRAM implant in people with Head and Neck Cancer and Oral Cancer, run by The Netherlands Cancer Institute at 1 site in Netherlands.
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 8 inclusion and 5 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: stopped early, as of the sponsor's last update on 24 Jul 2024. 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 Netherlands. 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?
The study was stopped early (reason given: End point is reached with 1 implant which is removed within the observation period). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgical fit (time frame: intra-operative). The study lists 2 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 24 Jul 2024.