Bone FractureNCT07518836
Efficacy and Safety of SurgiFill™in Patients With Femur or Tibia Fracture
A study testing femur or tibia fracture and SurgiFill™ in people with Bone Fracture and Tibia Fracture, run by Cellontech Co., Ltd. at 3 sites in South Korea.
Trial summary
This study is designed to investigate the safety and efficacy of SurgiFill™, a bone grafting material, in patients with femur or tibia fracture. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Bone Fracture, Tibia Fracture, Femur Fracture
- What is being tested?
- femur or tibia fracture and SurgiFill™
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 3 sitesSouth Korea
- Study dates
- Feb 2013to Dec 2016
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patients with closed fracture out of the joint from below the trochanter of the femur up to the distal femur or in the tibia
- Patients who agreed to participate in the study and signed the informed consent form
Who cannot join
- Patients or their family members with a history of an or an ongoing autoimmune disease
- Patients with a history of anaphylactic response
- Patients with hypersensitivity to grafting materials
- Patients with hypersensitivity to porcine protein
- Patients with osteomyelitis in the surgery area
- Patients who are pregnant, breastfeeding, or planning to become pregnant
Show all 16Show fewer
- Patients with other tumors or a non-curable disease
- Patients with a history of radiation therapy or cancer treatment within two years (Those who show normal or insignificant test results may be enrolled in this study and receive the SurgiFill™ injection based on the investigator's judgment.)
- Patients with diabetes (Those who maintain a normal blood sugar level and did not develop complications may receive the SurgiFill™ injection based on the investigator's judgment, but the doctor's confirmation is required.)
- Patients with an infection that required hospitalization for antibiotics or the administration of antiseptic agents
- Patients who have been undergoing adrenocortical hormone therapy (Those who show normal or insignificant test results may be enrolled in this study and receive the SurgiFill™ injection based on the investigator's judgment.)
- Patients with liver, heart, or kidney disease (Those who show normal or insignificant test results may be enrolled in this study and receive the SurgiFill™ injection based on the investigator's judgment. Hypertension patients are allowed.)
- Patients who had been infected with a virus (Those who show normal or insignificant test results may be enrolled in this study and receive the SurgiFill™ injection based on the investigator's judgment.)
- Patients with chronic renal failure or an endocrine system disease (Those who show normal or insignificant test results may be enrolled in this study and receive the SurgiFill™ injection based on the investigator's judgment.)
- Patients who are considered inappropriate for participation in this study due to their condition (e.g., a mental illness) based on the investigator's judgment
- Patients who had participated in another clinical trial (limited to those who participated in other studies on fracture within the last six months.)
Trial locations and contacts
3 sites in 1 country.
South Korea3 sites
Daejeon Sun Hospital
Daejeon, Daejeon
The Catholic University of Korea Seoul St. Mary's Hospital
Seoul, Seoul, 137701
The Catholic University of Korea Uijeongbu St. Mary's Hospital
Uijeongbu-si, Gyeonggi-do
About this study
Official title: A Clinical Trial to Investigate the Safety and Efficacy of SurgiFill™, a Bone Grafting Material, in Patients With Femur or Tibia Fracture.
This study is designed to investigate the safety and efficacy of SurgiFill™, a bone grafting material, in patients with femur or tibia fracture.
Read the detailed description
This study is an open-trial study. The purpose and procedure of study will be explained to the subjects, and they will voluntarily decide to participate in it. Their eligibility to participate in the study will be checked, and the subjects will be randomized into the study group or the control group (via stratified randomization) based on the severity of their disease and the surgery method. The study group will receive treatment for fracture (fixation) and SurgiFill™ injection, and the control group will receive only fracture treatment. For the fracture treatment, open-reduction internal fixation, a surgery method that involves incision of the fractured area and fixation with a metal plate or a metal nail, will be performed. They will be asked to follow the guidelines of the investigators during the study and to visit the hospital seven times, including for screening. At each visit, the subjects will undergo an examination with doctors and a X-ray procedure to evaluate the safety and efficacy of SurgiFill™.
- Conditions
- Bone Fracture, Tibia Fracture, Femur Fracture
- Being tested
- femur or tibia fracture, SurgiFill™
- Keywords
- Collagen, bone graft, Femoral and Tibial Fracture
- Medical subject headings
- Fractures, Bone, Tibial Fractures, Femoral Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
femur or tibia fractureProcedure or surgery
Also called Treatment for fracture, open-reduction internal fixation
For the fracture treatment, open-reduction internal fixation, a surgery method that involves incision of the fractured area and fixation with a metal plate or a metal nail, will be performed.
SurgiFill™Device
SurgiFill™ is a gel-type high-purity ateolcollagen for bone grafting. SurgiFill™ is an injection type.
| Study group | Role | What they receive |
|---|---|---|
| SurgiFill™ on femur or tibia fracture | Experimental | The study group will receive treatment for fracture and SurgiFill™ injection. Receives: Procedure: femur or tibia fracture; Device: SurgiFill™ |
| Treatment on femur or tibia fracture | Active comparator | The control group will receive only fracture treatment. Receives: Procedure: femur or tibia fracture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone formation completion date
The investigators will evaluate the bone formation and record the date of completion of the bone formation. The criteria for the bone formation completion are when the third callus has formed completely and when the patient no longer feels pain when he or she bears his or her full weight on his or her treated leg.
Measured: at time of bone formation completion
Secondary outcomes (3)
Callus Formation Score change
From the results of the X-rays at six, 10, 13, 16, and 22 weeks and every eight weeks thereafter, the investigators and radiographers will confirm if there is a new callus on the X-ray results; and if there is, they will record the scores separately (not together) from 0-2 and add them up.
Measured: post-op 6,10,13,16,22 weeks, and every 8 weeks thereafter.
Detailed callus formation date
The investigators and radiographers will record the periods of the first, second, third, and fourth callus formation and endosteal healing.
Measured: at the periods of the first, second, third, and fourth callus formation and endosteal healing.
Date of full weight bearing
The investigators and radiographers will record the date when the patient can already bear his or her full weight on the treated leg.
Measured: at time of full weight bearing available
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2026
- Study startFeb 2013
- Primary completionAug 2016
- Study completionDec 2016
Why it stopped: The study was terminated early due to company reasons.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone FractureStudies 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
- Randomised
- Intervention model
- Parallel groups
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cellontech Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Young Wook Yim, MD, Principal investigator, The Catholic University of KoreaJae Kwan Kong, MD, Principal investigator, The Catholic University of Korea, Uijeongbu St. Mary's HospitalJun Bum Kim, MD, Principal investigator, Daejeon Sun Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07518836
- Sponsor's protocol ID
- 01SGF
- Status last verified
- Aug 2015
- First submitted
- 28 Aug 2015
- Last updated
- 9 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Trial to Investigate the Safety and Efficacy of SurgiFill™, a Bone Grafting Material, in Patients With Femur or Tibia Fracture.
- ClinicalTrials.gov ID
- NCT07518836
- Acronym / sponsor ID
- 01SGF
- Conditions
- Bone Fracture, Tibia Fracture, Femur Fracture
- Keywords
- Collagen, bone graft, Femoral and Tibial Fracture
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated early due to company reasons.
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cellontech Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Feb 2013
- Primary completion
- Aug 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 9 Apr 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.
This study is designed to investigate the safety and efficacy of SurgiFill™, a bone grafting material, in patients with femur or tibia fracture.
Detailed description
This study is an open-trial study. The purpose and procedure of study will be explained to the subjects, and they will voluntarily decide to participate in it. Their eligibility to participate in the study will be checked, and the subjects will be randomized into the study group or the control group (via stratified randomization) based on the severity of their disease and the surgery method. The study group will receive treatment for fracture (fixation) and SurgiFill™ injection, and the control group will receive only fracture treatment. For the fracture treatment, open-reduction internal fixation, a surgery method that involves incision of the fractured area and fixation with a metal plate or a metal nail, will be performed. They will be asked to follow the guidelines of the investigators during the study and to visit the hospital seven times, including for screening. At each visit, the subjects will undergo an examination with doctors and a X-ray procedure to evaluate the safety and efficacy of SurgiFill™.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SurgiFill™ on femur or tibia fracture | Experimental | Procedure: femur or tibia fracture, Device: SurgiFill™The study group will receive treatment for fracture and SurgiFill™ injection. |
| Treatment on femur or tibia fracture | Active comparator | Procedure: femur or tibia fractureThe control group will receive only fracture treatment. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with closed fracture out of the joint from below the trochanter of the femur up to the distal femur or in the tibia
- Patients who agreed to participate in the study and signed the informed consent form
Key exclusion criteria (16 listed)
- Patients or their family members with a history of an or an ongoing autoimmune disease
- Patients with a history of anaphylactic response
- Patients with hypersensitivity to grafting materials
- Patients with hypersensitivity to porcine protein
- Patients with osteomyelitis in the surgery area
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 |
|---|---|---|
| femur or tibia fractureAlso: Treatment for fracture, open-reduction internal fixationFor the fracture treatment, open-reduction internal fixation, a surgery method that involves incision of the fractured area and fixation with a metal plate or a metal nail, will be performed. | Procedure or surgery | SurgiFill™ on femur or tibia fracture, Treatment on femur or tibia fracture |
| SurgiFill™SurgiFill™ is a gel-type high-purity ateolcollagen for bone grafting. SurgiFill™ is an injection type. | Device | SurgiFill™ on femur or tibia fracture |
Primary outcome
Bone formation completion date
Time frame: at time of bone formation completion
The investigators will evaluate the bone formation and record the date of completion of the bone formation. The criteria for the bone formation completion are when the third callus has formed completely and when the patient no longer feels pain when he or she bears his or her full weight on his or her treated leg.
3 secondary outcomes
Callus Formation Score change
Time frame: post-op 6,10,13,16,22 weeks, and every 8 weeks thereafter.
Detailed callus formation date
Time frame: at the periods of the first, second, third, and fourth callus formation and endosteal healing.
Date of full weight bearing
Time frame: at time of full weight bearing available
Results and safety
The study was stopped early (reason given: The study was terminated early due to company reasons.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2026.
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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.
Young Wook Yim, MD principal investigator
The Catholic University of Korea
Jae Kwan Kong, MD principal investigator
The Catholic University of Korea, Uijeongbu St. Mary's Hospital
Jun Bum Kim, MD principal investigator
Daejeon Sun Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing femur or tibia fracture and SurgiFill™ in people with Bone Fracture and Tibia Fracture, run by Cellontech Co., Ltd. at 3 sites in South Korea.
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 2 inclusion and 16 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 9 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 3 sites in South Korea. 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: The study was terminated early due to company reasons.). 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?
Bone formation completion date (time frame: at time of bone formation completion). 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 9 Apr 2026.