Reconstruction of Massive Bone Loss (Oncologic and Non-oncologic)IMPULSIONNCT07369778
Prospective Evaluation of Adler Laboratory's Massive Prosthetic Implants in Oncological and Non-oncological Situations
An observational study of Reconstruction of Massive Bone Loss (Oncologic and Non-oncologic), run by Nantes University Hospital at 1 site in France.
Trial summary
Massive prostheses are the standard treatment for extensive bone loss, whether caused by cancer or other factors (complex fractures, multiple revisions, infections). The emergence of modular systems such as the Pantheon range provides rapid restoration of function and precise intraoperative adaptation to anatomical… Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Reconstruction of Massive Bone Loss (Oncologic and Non-oncologic)
- How many people
- 375 participants
- Where
- 1 siteFrance
- Study dates
- 30 May 2026to 30 Jan 2036
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The population concerns patients with massive bone loss, because of oncological or non-oncological issue. Patients have massive prosthetic reconstruction using the Pantheon prosthesis from Adler Laboratories. The prostheses are: * Proximal Femur Recontruction (PFR) * Distal Femur Reconstruction (DFR) * Proximal Tibia Reconstruction (PTR) * Total Femur Reconstruction (TFR) * Custom implants Minors aged 15 and over may be included in the study, with no maximum age limit. Patient who has been informed about the study and doesn't object to participating.
Who may be able to join
- Patients aged 15 years or older at the time of inclusion
- Surgery scheduled at one of the participating centres with an Adler implant from the list below:
- Implants from the Pantheon prosthesis:
- Proximal Femur Recontruction (PFR) Distal Femur Reconstruction (DFR) Proximal Tibia Reconstruction (PTR) Total Femur Reconstruction (TFR) Hybrid connector implants Custom-made implants
- Follow-up scheduled at one of the participating centres for the duration of the study
- Patient who has been informed about the study and does not object to participating In the case of minor patients, the patient's parents will also be informed, and their non-objection will be sought.
- Patient affiliated with a Social Security scheme in France.
Who cannot join
- Patient or parent of a minor patient who objects to participation in the study and data collection.
- Patient deprived of liberty or under legal protection (guardianship or curatorship)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
CHU de Nantes
Nantes, 44093
Vincent CRENN, PU-PH, 02 40 08 48 25, vincent.crenn@chu-nantes.fr
Peggy Ageneau, 02 40 08 48 54, peggy.ageneau@chu-nantes.fr
About this study
Massive prostheses are the standard treatment for extensive bone loss, whether caused by cancer or other factors (complex fractures, multiple revisions, infections).
The emergence of modular systems such as the Pantheon range provides rapid restoration of function and precise intraoperative adaptation to anatomical constraints and specific bone loss characteristics.
Read more
The Pantheon range also offers an innovative intramedullary ring system that promotes osseointegration and potentially long-term mechanical stability of implants.
However, few studies have evaluated its clinical efficacy. In this context, a prospective cohort study is warranted in order to obtain robust data on implant survival, patient quality of life and predictors of medium- and long-term complications.
Read the detailed description
The IMPULSION study is an observational study. The primary objective is to evaluate prosthesis survival within 5 years post-operatively.
The secondary objectives are: to evaluate functional outcomes, quality of life, the occurrence of complications, and the osseointegration of the intramedullary ring.
Patients are included during the consultation to plan the surgery. Following surgery, the patient is followed up at 1 year, 2 years and 5 years post-operatively.
- Keywords
- Megaprosthesis, pantheon, Massive bone loss
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Femur reconstruction Proximal (PFR)/Distal (DFR)/Total (TFR), Proximal Tibia (PTR), Custom implants | Massive prosthetic reconstruction using the Pantheon prosthesis from Adler Laboratories. The prostheses are: * Proximal Femur Recontruction (PFR) * Distal Femur Reconstruction (DFR) * Proximal Tibia Reconstruction (PTR) * Total Femur Reconstruction (TFR) * Custom implants |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of prosthesis survival
The survival of the prosthesis is defined by the absence of revision surgery. This objective will be analysed in subgroups according to the type of implant used (PFR, DFR, PTR, TFR) or other implants (hybrid connector, custom-made).
Measured: 1 year, 2 years and 5 years post-operative
Secondary outcomes (4)
Evaluation of functional outcomes
MSTS score collected at inclusion, then post-operatively: 1 year after surgery (Y1), 2 years (Y2) and 5 years (Y5) As with the main objective, these objectives will be analysed in subgroups according to the type of implant used (PFR,DFR,PTR,TFR) or other implants (hybrid connector, custom-made).
Measured: 1 year after surgery (Y1), 2 years (Y2) and 5 years (Y5)
Evaluation of quality of life
EQ-5D-5L auto-questionnaire at inclusion, then post-operatively: 1 year after surgery (Y1), 2 years (Y2) and 5 years (Y5) As with the main objective, these objectives will be analysed in subgroups according to the type of implant used (PFR,DFR,PTR,TFR) or other implants (hybrid connector, custom-made).
Measured: 1 year after surgery (Y1), 2 years (Y2) and 5 years (Y5)
Evaluation of complications occurring within 5 years post-operatively
Complications coded according to the Henderson classification within 5 years post-operatively As with the main objective, these objectives will be analysed in subgroups according to the type of implant used (PFR,DFR,PTR,TFR) or other implants (hybrid connector, custom-made).
Measured: 1 year after surgery (Y1), 2 years (Y2) and 5 years (Y5)
Evaluation of osseointegration of the intramedullary ring
Radiographic analysis 1 year after surgery (Y1), 2 years (Y2) and 5 years (Y5) (4 cortical images on front and profile views): osseointegration Yes/No/Don't know As with the main objective, these objectives will be analysed in subgroups according to the type of implant used (PFR,DFR,PTR,TFR) or other implants (hybrid connector, custom-made).
Measured: 1 year after surgery (Y1), 2 years (Y2) and 5 years (Y5)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2026
- Study start30 May 2026 (estimated)
- Primary completion30 Jan 2030 (estimated)
- Study completion30 Jan 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Reconstruction of Massive Bone Loss (Oncologic and Non-oncologic)Studies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 375 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vincent CRENN, PU-PH, Principal investigator, Nantes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07369778
- Sponsor's protocol ID
- RC25_0215
- Acronym
- IMPULSION
- Status last verified
- Jan 2026
- First submitted
- 19 Jan 2026
- Last updated
- 14 Apr 2026
- 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 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of Adler Laboratory's Massive Prosthetic Implants in Oncological and Non-oncological Situations
- ClinicalTrials.gov ID
- NCT07369778
- Acronym / sponsor ID
- IMPULSION / RC25_0215
- Keywords
- Megaprosthesis, pantheon, Massive bone loss
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 375 participants (estimated)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 30 May 2026 (estimated)
- Primary completion
- 30 Jan 2030 (estimated)
- Study completion
- 30 Jan 2036 (estimated)
- First posted
- 27 Jan 2026 (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.
Massive prostheses are the standard treatment for extensive bone loss, whether caused by cancer or other factors (complex fractures, multiple revisions, infections).
The emergence of modular systems such as the Pantheon range provides rapid restoration of function and precise intraoperative adaptation to anatomical constraints and specific bone loss characteristics.
The Pantheon range also offers an innovative intramedullary ring system that promotes osseointegration and potentially long-term mechanical stability of implants.
However, few studies have evaluated its clinical efficacy. In this context, a prospective cohort study is warranted in order to obtain robust data on implant survival, patient quality of life and predictors of medium- and long-term complications.
Detailed description
The IMPULSION study is an observational study. The primary objective is to evaluate prosthesis survival within 5 years post-operatively.
The secondary objectives are: to evaluate functional outcomes, quality of life, the occurrence of complications, and the osseointegration of the intramedullary ring.
Patients are included during the consultation to plan the surgery. Following surgery, the patient is followed up at 1 year, 2 years and 5 years post-operatively.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Femur reconstruction Proximal (PFR)/Distal (DFR)/Total (TFR), Proximal Tibia (PTR), Custom implants | – | –Massive prosthetic reconstruction using the Pantheon prosthesis from Adler Laboratories. The prostheses are: * Proximal Femur Recontruction (PFR) * Distal Femur Reconstruction (DFR) * Proximal Tibia Reconstruction (PTR) * Total Femur Reconstruction (TFR) * Custom implants |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The population concerns patients with massive bone loss, because of oncological or non-oncological issue. Patients have massive prosthetic reconstruction using the Pantheon prosthesis from Adler Laboratories. The prostheses are: * Proximal Femur Recontruction (PFR) * Distal Femur Reconstruction (DFR) * Proximal Tibia Reconstruction (PTR) * Total Femur Reconstruction (TFR) * Custom implants Minors aged 15 and over may be included in the study, with no maximum age limit. Patient who has been informed about the study and doesn't object to participating.
Key inclusion criteria (7 listed)
- Patients aged 15 years or older at the time of inclusion
- Surgery scheduled at one of the participating centres with an Adler implant from the list below:
- Proximal Femur Recontruction (PFR) Distal Femur Reconstruction (DFR) Proximal Tibia Reconstruction (PTR) Total Femur Reconstruction (TFR) Hybrid connector implants Custom-made implants
- Follow-up scheduled at one of the participating centres for the duration of the study
- Patient who has been informed about the study and does not object to participating In the case of minor patients, the patient's parents will also be informed, and their non-objection will be sought.
Key exclusion criteria (2 listed)
- Patient or parent of a minor patient who objects to participation in the study and data collection.
- Patient deprived of liberty or under legal protection (guardianship or curatorship)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Evaluation of prosthesis survival
Time frame: 1 year, 2 years and 5 years post-operative
The survival of the prosthesis is defined by the absence of revision surgery. This objective will be analysed in subgroups according to the type of implant used (PFR, DFR, PTR, TFR) or other implants (hybrid connector, custom-made).
4 secondary outcomes
Evaluation of functional outcomes
Time frame: 1 year after surgery (Y1), 2 years (Y2) and 5 years (Y5)
Evaluation of quality of life
Time frame: 1 year after surgery (Y1), 2 years (Y2) and 5 years (Y5)
Evaluation of complications occurring within 5 years post-operatively
Time frame: 1 year after surgery (Y1), 2 years (Y2) and 5 years (Y5)
Evaluation of osseointegration of the intramedullary ring
Time frame: 1 year after surgery (Y1), 2 years (Y2) and 5 years (Y5)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2026.
- Individual participant dataSharing planned: No
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.
Vincent CRENN, PU-PH principal investigator
Nantes University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Reconstruction of Massive Bone Loss (Oncologic and Non-oncologic), run by Nantes University Hospital at 1 site in France.
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 7 inclusion and 2 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: opening soon, as of the sponsor's last update on 14 Apr 2026. 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 France. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Vincent CRENN, PU-PH (+33 2 44 76 80 58, Vincent.Crenn@univ-nantes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of prosthesis survival (time frame: 1 year, 2 years and 5 years post-operative). 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 14 Apr 2026.