Primary and Secondary Bone Tumor in the Proximal Femur RegionKRIOSNCT05847868
Clinical Evaluation of Moment Tumor Hip Replacement Products
A study testing Moment Tumour Hip Prothesis in people with Primary and Secondary Bone Tumor in the Proximal Femur Region, run by Estas Tıbbi Mamülleri Medikal at 7 sites in Turkey (Türkiye).
Trial summary
The aim is to ensure that the patients are functionally adequately and painlessly mobilized with the proximal femoral tumor resection prosthesis used, to increase the survival of patients who underwent wide resection, and to determine the complications of the treatment applied and the clinical performance of the… Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Primary and Secondary Bone Tumor in the Proximal Femur Region
- What is being tested?
- Moment Tumour Hip Prothesis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 7 sitesTurkey (Türkiye)
- Study dates
- 16 Mar 2023to 30 Jun 2025
- 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 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults of both sexes aged 18-79 years
- For patients with bone loss, fractures, pseudarthrosis due to primary-secondary metastases in the hip femoral region, patients belonging to one or more of the following groups
- Patients with or with bone resections due to infection
- Patients with unsuccessful femoral component applications
- Patients in need of long-term stabilization of major bone defects caused by fractures with major and irreversible bone loss, periprosthetic fractures, traumatic non-tumor conditions affecting the trunks of the long bones, and comminuted fractures
- Patients with severe pain and loss of function in the proximal femoral region
- Patients with incompetence of the upper end of the femur or femoral neck fracture in hip replacement revisions.
- Have sufficient mental and physical capacity to sign the informed consent form for the procedure
Who cannot join
- Be under the age of 18 and over the age of 79
- Pregnancy
- Breastfeeding
- Patients with bone tumors near the implant
- Patients with acute or chronic infections (local or systemic) that reduce the adhesion resistance of the implant.
- Patients with defective bone structures that may prevent proper fixation of the implant and severe deterioration or axial deviation affecting bone quality
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- Patients with inadequate bone quantity and quality as a result of osteoporosis
- Patients with underdeveloped skeletal structure
- Patients with vascular and neuromuscular disorders or muscular dystrophy and advanced muscle atrophy
- Patients with impaired blood flow caused by vascular changes due to previous surgical procedure, alcohol use, etc.
- Patients with more than expected implant overload due to obesity and/or vigorous physical activity or strain (such as sports, activities requiring physical activity)
- Patients with inflammatory degenerative joint disease
- Patients with pathologies that prevent surgical intervention
- Patients whose general condition is not good and who cannot handle anesthesia
- Patients who are uncoordinated or unwilling to operate, or who cannot follow instructions
- Patients with mental retardation who do not or cannot comply with post-operative care instructions
- Patients with neuropathic osteoarthropathy (charcot joint) joint disease
- Patients with multiple organ failure
- Patients with sepsis
- Patients with syndromes or concomitant diseases that may adversely affect the evaluation of patients due to its systematic involvement.
- Patients whose follow-up is not clinically or ethically appropriate due to complications that may develop during the study
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Turkey (Türkiye)7 sites
Gazi University Faculty of Medicine
Ankara
Hacettepe University Faculty of Medicine
Ankara
Pamukkale University Faculty of Medicine
Denizli
Eskişehir Osmangazi University Health Practice and Research Hospital
Eskişehir
Istanbul Göztepe Prof.Dr. Suleyman Yalcin City Hospital
Istanbul
Necmettin Erbakan University Meram Faculty of Medicine
Konya
Cumhuriyet University School of Medicine
Sivas
About this study
Official title: Clinical Evaluation of Moment Tumor Hip Replacement Products Within the Scope of Substantial Clinical Trials
The aim is to ensure that the patients are functionally adequately and painlessly mobilized with the proximal femoral tumor resection prosthesis used, to increase the survival of patients who underwent wide resection, and to determine the complications of the treatment applied and the clinical performance of the Moment Tumor Hip Replacement Products used.
Read the detailed description
This study is a 6-center, prospective local medical device clinical trial. Trial period is 6 months. Patient recruitment will continue until the target sample number determined by the power analysis is reached. Since the application is surgical, it is within the scope of a one-time application. The patients will be followed for 6 months from the day of surgery. The study was designed as a prospective cohort study planned to be cross-sectional. The aim of this study is to ensure that the patients are functionally adequately and painlessly mobilized with the proximal femoral tumor resection prosthesis used, to increase the survival of patients who underwent wide resection, and to determine the complications of the treatment applied and the clinical performance of the Moment Tumor Hip Replacement Products used and to contribute to the medical literature on proximal femoral resection prosthesis as a result of the study.
- Being tested
- Moment Tumour Hip Prothesis
- Keywords
- hip, pain, fracture, inability, proximal
- Medical subject headings
- Pain, Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moment Tumour Hip ProthesisDevice
In the case of irreversible bone loss due to bone tumors, large and multi-part fractures, and pseudarthrosis in the proximal region of the femur bone, the defective bone area is removed and implants made of artificial materials are placed in order to replace the integrity of the bone. In addition, implant applications are made to the proximal femur region for the purpose of revision arthroplasty, which is typically replaced by total hip prosthesis depending on the wear condition.
In this way, the bone integrity will be preserved, long-term stabilization will be provided to the patient and existing pain will be eliminated.
Moment Tumor Hip Replacement Systems consist of proximal main body, extension pieces and intramedullary stems. Components are available in a variety of sizes to meet anatomical requirements and surgeon needs.
| Study group | Role | What they receive |
|---|---|---|
| Device Feasibility | Experimental | Device feasibility will be performed in this single arm study. Receives: Device: Moment Tumour Hip Prothesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Adverse Events
Reliability of the procedure (adverse events occurring)
Measured: 6 Months
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Toleratibily of the patients for the procedure.
Measured: 6 Months
Hip pain and function for 6 months after the procedure according to the MSTS scoring
Hip pain and function for 6 months after the procedure according to the MSTS scoring
Measured: 6 Months
Change in Quality of life
Determination of the change in quality of life from baseline to 6 month after the procedure
Measured: 6 Months
Secondary outcomes (3)
Improvement in Functional Parameters
Percent change in in functional parameters compared to baseline during the follow-up period.
Measured: 6 Months
Complications
Complications will be evaluated in patients with complications according to the Henderson classification.
Measured: 6 Months
Procedure's Safety
Number of adverse event: observed adverse events (AE) with the help of radiographic evaluations and Examinations performed
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2023
- Study start16 Mar 2023
- Primary completion30 Jun 2025
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary and Secondary Bone Tumor in the Proximal Femur RegionStudies 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Estas Tıbbi Mamülleri Medikal
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Klinar CRO
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05847868
- Sponsor's protocol ID
- K-BE001-KRIOS
- Acronym
- KRIOS
- Status last verified
- Jun 2025
- First submitted
- 7 Apr 2023
- Last updated
- 3 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There i no plan to share IPD
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Moment Tumor Hip Replacement Products Within the Scope of Substantial Clinical Trials
- ClinicalTrials.gov ID
- NCT05847868
- Acronym / sponsor ID
- KRIOS / K-BE001-KRIOS
- Keywords
- hip, pain, fracture, inability, proximal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Estas Tıbbi Mamülleri MedikalIndustry (pharma, biotech, devices)
- Collaborators
- Klinar CRO
- Study start
- 16 Mar 2023 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 8 May 2023 (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 aim is to ensure that the patients are functionally adequately and painlessly mobilized with the proximal femoral tumor resection prosthesis used, to increase the survival of patients who underwent wide resection, and to determine the complications of the treatment applied and the clinical performance of the Moment Tumor Hip Replacement Products used.
Detailed description
This study is a 6-center, prospective local medical device clinical trial. Trial period is 6 months. Patient recruitment will continue until the target sample number determined by the power analysis is reached. Since the application is surgical, it is within the scope of a one-time application. The patients will be followed for 6 months from the day of surgery. The study was designed as a prospective cohort study planned to be cross-sectional. The aim of this study is to ensure that the patients are functionally adequately and painlessly mobilized with the proximal femoral tumor resection prosthesis used, to increase the survival of patients who underwent wide resection, and to determine the complications of the treatment applied and the clinical performance of the Moment Tumor Hip Replacement Products used and to contribute to the medical literature on proximal femoral resection prosthesis as a result of the study.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Device Feasibility | Experimental | Device: Moment Tumour Hip ProthesisDevice feasibility will be performed in this single arm study. |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Adults of both sexes aged 18-79 years
- For patients with bone loss, fractures, pseudarthrosis due to primary-secondary metastases in the hip femoral region, patients belonging to one or more of the following groups
- Patients with or with bone resections due to infection
- Patients with unsuccessful femoral component applications
- Patients in need of long-term stabilization of major bone defects caused by fractures with major and irreversible bone loss, periprosthetic fractures, traumatic non-tumor conditions affecting the trunks of the long bones, and comminuted fractures
Key exclusion criteria (21 listed)
- Be under the age of 18 and over the age of 79
- Pregnancy
- Breastfeeding
- Patients with bone tumors near the implant
- Patients with acute or chronic infections (local or systemic) that reduce the adhesion resistance of the implant.
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 |
|---|---|---|
| Moment Tumour Hip ProthesisIn the case of irreversible bone loss due to bone tumors, large and multi-part fractures, and pseudarthrosis in the proximal region of the femur bone, the defective bone area is removed and implants made of artificial materials are placed in order to replace the integrity of the bone. In addition, implant applications are made to the proximal femur region for the purpose of revision arthroplasty, which is typically replaced by total hip prosthesis depending on the wear condition. In this way, the bone integrity will be preserved, long-term stabilization will be provided to the patient and existing pain will be eliminated. Moment Tumor Hip Replacement Systems consist of proximal main body, extension pieces and intramedullary stems. Components are available in a variety of sizes to meet anatomical requirements and surgeon needs. | Device | Device Feasibility |
Primary outcome
Rate of Adverse Events
Time frame: 6 Months
Reliability of the procedure (adverse events occurring)
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: 6 Months
Toleratibily of the patients for the procedure.
Hip pain and function for 6 months after the procedure according to the MSTS scoring
Time frame: 6 Months
Hip pain and function for 6 months after the procedure according to the MSTS scoring
Change in Quality of life
Time frame: 6 Months
Determination of the change in quality of life from baseline to 6 month after the procedure
3 secondary outcomes
Improvement in Functional Parameters
Time frame: 6 Months
Complications
Time frame: 6 Months
Procedure's Safety
Time frame: 6 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2025.
- Individual participant dataSharing planned: No. There i no plan to share IPD
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.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Moment Tumour Hip Prothesis in people with Primary and Secondary Bone Tumor in the Proximal Femur Region, run by Estas Tıbbi Mamülleri Medikal at 7 sites in Turkey (Türkiye).
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 21 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: finished, as of the sponsor's last update on 3 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Turkey (Türkiye). 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Rate of Adverse Events (time frame: 6 Months). The study lists 4 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 3 Jul 2025.