Clinical Evaluation of Moment Tumor Hip Replacement Products

NCT05847868 | Completed

• 1 other identifier: K-BE001-KRIOS
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 7

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.

Conditions

Primary and Secondary Bone Tumor in the Proximal Femur Region

Keywords

hip; pain; fracture; inability; proximal

Outcome Measures

Primary Outcomes (4)

• Rate of Adverse Events

  Reliability of the procedure (adverse events occurring)

  6 Months

• Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

  Toleratibily of the patients for the procedure.

  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

  6 Months

• Change in Quality of life

  Determination of the change in quality of life from baseline to 6 month after the procedure

  6 Months

Secondary Outcomes (3)

• Improvement in Functional Parameters

  6 Months

• Complications

  6 Months

• Procedure's Safety

  6 Months

Study Arms (1)

Device Feasibility

EXPERIMENTAL

Device feasibility will be performed in this single arm study.

Device: Moment Tumour Hip Prothesis

Interventions

Moment Tumour Hip Prothesis DEVICE

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.

Device Feasibility

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Estas Tıbbi Mamülleri Medikal: lead
• Klinar CRO: collaborator

Study Sites (7)

Gazi University Faculty of Medicine

Ankara, Turkey (Türkiye)

Location

Hacettepe University Faculty of Medicine

Ankara, Turkey (Türkiye)

Location

Pamukkale University Faculty of Medicine

Denizli, Turkey (Türkiye)

Location

Eskişehir Osmangazi University Health Practice and Research Hospital

Eskişehir, Turkey (Türkiye)

Location

Istanbul Göztepe Prof.Dr. Suleyman Yalcin City Hospital

Istanbul, Turkey (Türkiye)

Location

Necmettin Erbakan University Meram Faculty of Medicine

Konya, Turkey (Türkiye)

Location

Cumhuriyet University School of Medicine

Sivas, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain; Fractures, Bone

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2023
• First Posted: May 8, 2023
• Study Start: March 16, 2023
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: July 3, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (7)