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Clinical Evaluation of Moment Tumor Hip Replacement Products (KRIOS)

Primary Purpose

Primary and Secondary Bone Tumor in the Proximal Femur Region

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Moment Tumour Hip Prothesis
Sponsored by
Estas Tıbbi Mamülleri Medikal
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Primary and Secondary Bone Tumor in the Proximal Femur Region focused on measuring hip, pain, fracture, inability, proximal

Eligibility Criteria

18 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 Exclusion Criteria: 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 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

Sites / Locations

  • Gazi University Faculty of MedicineRecruiting
  • Hacettepe University Faculty of MedicineRecruiting
  • Pamukkale University Faculty of MedicineRecruiting
  • Eskişehir Osmangazi University Health Practice and Research HospitalRecruiting
  • Istanbul Göztepe Prof.Dr. Suleyman Yalcin City HospitalRecruiting
  • Necmettin Erbakan University Meram Faculty of MedicineRecruiting
  • Cumhuriyet University School of MedicineRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Device Feasibility

Arm Description

Device feasibility will be performed in this single arm study.

Outcomes

Primary Outcome Measures

Rate of Adverse Events
Reliability of the procedure (adverse events occurring)
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Toleratibily of the patients for the procedure.
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
Change in Quality of life
Determination of the change in quality of life from baseline to 6 month after the procedure

Secondary Outcome Measures

Improvement in Functional Parameters
Percent change in in functional parameters compared to baseline during the follow-up period.
Complications
Complications will be evaluated in patients with complications according to the Henderson classification.
Procedure's Safety
Number of adverse event: observed adverse events (AE) with the help of radiographic evaluations and Examinations performed

Full Information

First Posted
April 7, 2023
Last Updated
May 4, 2023
Sponsor
Estas Tıbbi Mamülleri Medikal
Collaborators
Klinar CRO
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1. Study Identification

Unique Protocol Identification Number
NCT05847868
Brief Title
Clinical Evaluation of Moment Tumor Hip Replacement Products
Acronym
KRIOS
Official Title
Clinical Evaluation of Moment Tumor Hip Replacement Products Within the Scope of Substantial Clinical Trials
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 16, 2023 (Actual)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
August 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Estas Tıbbi Mamülleri Medikal
Collaborators
Klinar CRO

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary and Secondary Bone Tumor in the Proximal Femur Region
Keywords
hip, pain, fracture, inability, proximal

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Device Feasibility
Arm Type
Experimental
Arm Description
Device feasibility will be performed in this single arm study.
Intervention Type
Device
Intervention Name(s)
Moment Tumour Hip Prothesis
Intervention Description
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.
Primary Outcome Measure Information:
Title
Rate of Adverse Events
Description
Reliability of the procedure (adverse events occurring)
Time Frame
6 Months
Title
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Description
Toleratibily of the patients for the procedure.
Time Frame
6 Months
Title
Hip pain and function for 6 months after the procedure according to the MSTS scoring
Description
Hip pain and function for 6 months after the procedure according to the MSTS scoring
Time Frame
6 Months
Title
Change in Quality of life
Description
Determination of the change in quality of life from baseline to 6 month after the procedure
Time Frame
6 Months
Secondary Outcome Measure Information:
Title
Improvement in Functional Parameters
Description
Percent change in in functional parameters compared to baseline during the follow-up period.
Time Frame
6 Months
Title
Complications
Description
Complications will be evaluated in patients with complications according to the Henderson classification.
Time Frame
6 Months
Title
Procedure's Safety
Description
Number of adverse event: observed adverse events (AE) with the help of radiographic evaluations and Examinations performed
Time Frame
6 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mustafa Cetin
Phone
0090534 461 72 58
Email
mustafa.cetin@estas.com.tr
Facility Information:
Facility Name
Gazi University Faculty of Medicine
City
Ankara
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sefik Murat Arıkan
Facility Name
Hacettepe University Faculty of Medicine
City
Ankara
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mehmet Ayvaz
Facility Name
Pamukkale University Faculty of Medicine
City
Denizli
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ahmet Nadir Aydemir
Facility Name
Eskişehir Osmangazi University Health Practice and Research Hospital
City
Eskisehir
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ulukan Inan
Facility Name
Istanbul Göztepe Prof.Dr. Suleyman Yalcin City Hospital
City
Istanbul
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Korhan Ozkan
Facility Name
Necmettin Erbakan University Meram Faculty of Medicine
City
Konya
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tahsin Sami Çolak
Facility Name
Cumhuriyet University School of Medicine
City
Sivas
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zekeriya Oztemur

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There i no plan to share IPD

Learn more about this trial

Clinical Evaluation of Moment Tumor Hip Replacement Products

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