Fracture of Neck of FemurNCT06713031
Medial Enhancement Technique for the Treatment of Old Femoral Neck Fractures
A study testing cannulated compression screws + iliac bone graft and DCS + medial support plate + iliac bone graft in people with Fracture of Neck of Femur, run by Chinese PLA General Hospital at 1 site in China.
Trial summary
A prospective, multi-center, randomized controlled study was conducted to validate the safety and effectiveness of employing the medial augmentation technique (incorporating the dynamic condylar screw and medial support plate) supplemented with bone grafting for the treatment of old femoral neck fractures. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fracture of Neck of Femur
- What is being tested?
- cannulated compression screws + iliac bone graft and DCS + medial support plate + iliac bone graft
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- 10 Dec 2024to 31 Oct 2026
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >= 18 years, gender not specified;
- Patients with femoral neck fractures who have not undergone surgery for more than 3 weeks, or patients with persistent non-union following internal fixation of femoral neck fractures;
- Have indications for internal fixation surgery for femoral neck fractures and are able to tolerate the surgery;
- Participants or their legal representatives are informed about the nature of this study and agree to participate.
Who cannot join
- Participants who have not reached the primary endpoint of other drug, biological agent, or medical device clinical trials prior to enrollment;
- Known history of hypersensitivity to one or more implanted materials by the patient;
- Judged by the investigator as physically frail or unable to tolerate surgery due to other systemic diseases;
- Active infectious foci in the hip joint or other parts of the body, as judged by the investigator;
- Diagnosed with metabolic bone disease, radiation-induced bone disease, etc.;
- Severe hip contracture deformity or severe muscle weakness that has been immobilized in functional position for a long time and painless;
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- Suffering from inflammatory arthritis, such as rheumatoid arthritis, systemic lupus erythematosus arthritis, ankylosing spondylitis, etc.;
- Patients who lack the mental capacity or understanding to meet the requirements of participating in the study, or are difficult to cooperate with;
- Other situations where the investigator deems the participant unsuitable for inclusion.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Prospective, Multicenter, Randomized Controlled Clinical Study of Medial Enhancement Technique for the Treatment of Old Femoral Neck Fractures
A prospective, multi-center, randomized controlled study was conducted to validate the safety and effectiveness of employing the medial augmentation technique (incorporating the dynamic condylar screw and medial support plate) supplemented with bone grafting for the treatment of old femoral neck fractures.
- Conditions
- Fracture of Neck of Femur
- Being tested
- cannulated compression screws + iliac bone graft, DCS + medial support plate + iliac bone graft
- Keywords
- cannulated compression screws with iliac bone graft, Medial enhancement technique with iliac bone graft
- Medical subject headings
- Femoral Neck Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cannulated compression screws + iliac bone graftProcedure or surgery
Using "cannulated compression screws + iliac bone graft" technique to treat old femoral neck fractures
DCS + medial support plate + iliac bone graftProcedure or surgery
Using "DCS + medial support plate + iliac bone graft" technique to treat old femoral neck fractures
| Study group | Role | What they receive |
|---|---|---|
| Cannulated compression screws + iliac bone graft group | Placebo comparator | Not described Receives: Procedure: cannulated compression screws + iliac bone graft |
| DCS + medial support plate + iliac bone graft group | Experimental | Not described Receives: Procedure: DCS + medial support plate + iliac bone graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fracture healing rate
Measured: 1 year
Secondary outcomes (4)
Femoral head necrosis
Commonly used imaging tools include X-rays, Magnetic Resonance Imaging (MRI), and Computerized Tomography (CT). X-rays are the most commonly employed assessment tool, capable of displaying the morphology of the femoral head and whether the bone structure is normal. MRI and CT can provide more detailed images, aiding in the determination of the extent and range of femoral head necrosis.
Measured: 1 year
Harris score
The Harris Score (Harris Hip Score, HHS) is a widely used scale for evaluating hip joint function and patient quality of life, often applied to assess the outcomes of hip replacement surgery or other treatments for hip joint diseases. It covers four main aspects: pain level, functional activity, joint range of motion, and hip joint deformity. The total score ranges from 0 to 100, with 100 being the best possible condition, indicating complete normalcy of hip joint function.
Measured: 1 year
VAS score
The VAS score (Visual Analog Scale) is a commonly used tool for quantifying pain assessment that is suitable for measuring various degrees of pain. The VAS score typically employs a straight line 10 centimeters long (or an equivalent visual scale), with each end marked as "No Pain" and "Most Intense Pain" respectively. A straight line 10 centimeters long (or an equivalent visual scale) is often utilized, with each end labeled as "No Pain" and "Most Intense Pain."
Measured: 1 year
Complications
Focusing on perioperative complications in patients, indications and symptoms of incision infection, including redness, swelling, drainage, and fever, should be carefully monitored. The incidence and severity of infection cases should be recorded and analyzed to evaluate the risk factors for postoperative infection and the effectiveness of preventive strategies. Unplanned reoperations should be recorded, including cases of primary surgery failure, development of complications, or other situations necessitating further surgical intervention. Detailed records of the causes, timing, and outcomes of reoperations will help evaluate the reliability of surgical techniques and internal fixation devices. Additionally, other postoperative complications, such as femoral head necrosis, repositioning of fracture ends, fixation loosening and breakage, should be meticulously recorded and observed.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2024
- Study start10 Dec 2024 (estimated)
- Primary completion10 Dec 2024 (estimated)
- Study completion31 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fracture of Neck of FemurStudies of the same condition, open and under way.
- More trials run by Chinese PLA General 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhang Wei, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06713031
- Sponsor's protocol ID
- S2024-342-01
- Status last verified
- Dec 2024
- First submitted
- 16 Nov 2024
- Last updated
- 4 Dec 2024
- Results posted
- 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 4 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Multicenter, Randomized Controlled Clinical Study of Medial Enhancement Technique for the Treatment of Old Femoral Neck Fractures
- ClinicalTrials.gov ID
- NCT06713031
- Acronym / sponsor ID
- S2024-342-01
- Conditions
- Fracture of Neck of Femur
- Keywords
- cannulated compression screws with iliac bone graft, Medial enhancement technique with iliac bone graft
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- 10 Dec 2024 (estimated)
- Primary completion
- 10 Dec 2024 (estimated)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 3 Dec 2024 (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.
A prospective, multi-center, randomized controlled study was conducted to validate the safety and effectiveness of employing the medial augmentation technique (incorporating the dynamic condylar screw and medial support plate) supplemented with bone grafting for the treatment of old femoral neck fractures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cannulated compression screws + iliac bone graft group | Placebo comparator | Procedure: cannulated compression screws + iliac bone graft |
| DCS + medial support plate + iliac bone graft group | Experimental | Procedure: DCS + medial support plate + iliac bone graft |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age >= 18 years, gender not specified;
- Patients with femoral neck fractures who have not undergone surgery for more than 3 weeks, or patients with persistent non-union following internal fixation of femoral neck fractures;
- Have indications for internal fixation surgery for femoral neck fractures and are able to tolerate the surgery;
- Participants or their legal representatives are informed about the nature of this study and agree to participate.
Key exclusion criteria (9 listed)
- Participants who have not reached the primary endpoint of other drug, biological agent, or medical device clinical trials prior to enrollment;
- Known history of hypersensitivity to one or more implanted materials by the patient;
- Judged by the investigator as physically frail or unable to tolerate surgery due to other systemic diseases;
- Active infectious foci in the hip joint or other parts of the body, as judged by the investigator;
- Diagnosed with metabolic bone disease, radiation-induced bone disease, etc.;
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 |
|---|---|---|
| cannulated compression screws + iliac bone graftUsing "cannulated compression screws + iliac bone graft" technique to treat old femoral neck fractures | Procedure or surgery | Cannulated compression screws + iliac bone graft group |
| DCS + medial support plate + iliac bone graftUsing "DCS + medial support plate + iliac bone graft" technique to treat old femoral neck fractures | Procedure or surgery | DCS + medial support plate + iliac bone graft group |
Primary outcome
Fracture healing rate
Time frame: 1 year
4 secondary outcomes
Femoral head necrosis
Time frame: 1 year
Harris score
Time frame: 1 year
VAS score
Time frame: 1 year
Complications
Time frame: 1 year
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 4 Dec 2024.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cannulated compression screws + iliac bone graft and DCS + medial support plate + iliac bone graft in people with Fracture of Neck of Femur, run by Chinese PLA General Hospital at 1 site in China.
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 4 inclusion and 9 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 4 Dec 2024. 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 China. 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. Some participants in this study may receive a placebo. 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 Wei Zhang (+8612409252, bszw@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fracture healing rate (time frame: 1 year). 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 4 Dec 2024.