Femoral Neck FracturesNCT04959370
Comparison of Clinical Efficacy Between Dynamic Dip Screw and Cannulated Compression Screw for Fresh Femoral Neck Fracture
A study testing internal fixation implantation of dynamic hip screw and internal fixation implantation of cannulated compression screw in people with Femoral Neck Fractures, run by Peking University Third Hospital at 1 site in China.
Trial summary
For fresh femoral neck fracture internal fixation, both DHS and CCS can make strong fixation of hip and have good recovery. There is no statistical difference in complications after surgery between the two procedures. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Femoral Neck Fractures
- What is being tested?
- internal fixation implantation of dynamic hip screw and internal fixation implantation of cannulated compression screw
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 91 participants
- Where
- 1 siteChina
- Study dates
- Jan 2012to Sep 2018
- 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 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- fresh femoral neck fracture
- can walk before fracture
- less than 65 years old
Who cannot join
- Patients combined with other bone fractures.
- Pathological fracture (e.g., primary or metastatic tumor)
- Serious soft tissue injury, judged by the investigator, will impact the union of the fracture, combined open fractures, vascular injury, and combined osteofascial compartment syndrome.
- Multiple systemic injuries judged by researchers not suitable for enrollment. Revision surgeries (for example, due to malunion, nonunion or infection)
- Concurrent medical conditions judged by researchers not suitable for enrollment, such as: metabolic bone disease, post-polio syndrome, poor bone quality, prior history of poor fracture healing, etc
- Patients known to be allergic to implant components
- Patients who are currently using chemotherapeutics or accepting radiotherapy, use systematically corticosteroid hormone or growth factor, or long-term use sedative hypnotics (continuous use over 3 months) or non-steroidal anti-inflammatory drugs (continuous use over 3 months)
- Subjects have significant neurological or musculoskeletal disorders or may have adverse effects on gait or weight-bearing (e.g., muscular dystrophy, multiple sclerosis, cerebral infarction, hemiplegia, Charcot arthropathy, avascular necrosis of the femoral head).
Trial locations and contacts
1 site in 1 country.
China1 site
Peking University Third Hospital
Beijing, Beijing Municipality, 100191
About this study
For fresh femoral neck fracture internal fixation, both DHS and CCS can make strong fixation of hip and have good recovery. There is no statistical difference in complications after surgery between the two procedures. Patients with DHS internal fixation have earlier postoperative weight bearing, which is conducive to functional exercise of the injured limb. DHS internal fixation system is recommended for patients with unstable fractures and severe osteoporosis.
Read the detailed description
Objective: To compare the clinical effect of dynamic hip screw (DHS) and cannulated compression screw (CCS) in the treatment of fresh femoral neck fracture. Methods: A retrospective study was conducted to analyze the data of 91 patients with fresh femoral neck fracture treated with DHS or CCS in our hospital from January 2012 to June 2016.The cases were divided into two groups according to internal fixation: 44 cases in the DHS group and 47 cases in the CCS group. By comparing operative time, intraoperative bleeding, postoperative load, Harris scoring and the complications such as postoperative necrosis of femoral head and shortening of femoral neck appearance, we evaluated the clinical curative effect of two kinds of fixation.
- Conditions
- Femoral Neck Fractures
- Being tested
- internal fixation implantation of dynamic hip screw, internal fixation implantation of cannulated compression screw
- Keywords
- Femoral neck fracture, Internal fixation of fracture, Dynamic hip screw, Cannulated compression screw
- 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.
internal fixation implantation of dynamic hip screwDevice
Dynamic hip screws (DHS) are a femoral head-sparing orthopedic device used to treat femoral neck fractures.
internal fixation implantation of cannulated compression screwDevice
Cannulated Screw is designed to provide a minimally invasive method of anatomical fixation.
| Study group | Role | What they receive |
|---|---|---|
| Dynamic hip screw (DHS) | Experimental | Not described Receives: Device: internal fixation implantation of dynamic hip screw |
| Cannulated compression screw (CCS) | Active comparator | Not described Receives: Device: internal fixation implantation of cannulated compression screw |
What is being measured
The primary outcome is the main question the study is designed to answer.
Internal fixation failure rate
defined as the total incidence of internal plant cut-out and fracture.
Measured: from operation to 1-year follow-up after the surgery
Secondary outcomes (7)
Number of Participants with Bone nonunion
evaluate bone healing according to the lateral X-ray examination. According to the regulations of Food and Drug Administration of the US, if there are no obvious signs of fracture healing 9 months after the fracture, or if there is no obvious difference in fracture space after three consecutive months, it is defined as nonunion.
Measured: from operation to 1-year follow-up after the surgery
Harris hip score
the score value is from 0 to 100, and a higher score means a better outcome
Measured: from operation to 1-year follow-up after the surgery
operation time
from the incision to internal fixation implanted
Measured: intraoperation
The times of intraoperative fluoroscopy
average 25 milliseconds per X-ray shot, record the number of X-ray shot
Measured: intraoperation
Number of Participants with Postoperative adverse events
including ipsilateral femoral head avascular necrosis, infection, wound hematoma, ipsilateral coxa vara, and ipsilateral limb shortening
Measured: from operation to 1-year follow-up after the surgery
Garden index
The fracture reduction will be considered unsatisfied if the index is less than 155 degrees or more than 180 degrees.
Measured: from operation to 1-year follow-up after the surgery
A 12-Item Short-Form Health Survey (SF-12)
the score value is from 0 to 100, and a higher score means a better outcome
Measured: from operation to 1-year follow-up after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2021
- Study startJan 2012
- Primary completionJun 2016
- Study completionSep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Femoral Neck FracturesStudies of the same condition, open and under way.
- More trials run by Peking University Third 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04959370
- Sponsor's protocol ID
- PekingUTH ZF DHS
- Status last verified
- Jul 2021
- First submitted
- 2 Jul 2021
- Last updated
- 13 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Clinical Efficacy Between Dynamic Dip Screw and Cannulated Compression Screw for Fresh Femoral Neck Fracture
- ClinicalTrials.gov ID
- NCT04959370
- Acronym / sponsor ID
- PekingUTH ZF DHS
- Conditions
- Femoral Neck Fractures
- Keywords
- Femoral neck fracture, Internal fixation of fracture, Dynamic hip screw, Cannulated compression screw
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- Jan 2012 (actual)
- Primary completion
- Jun 2016 (actual)
- Study completion
- Sep 2018 (actual)
- First posted
- 13 Jul 2021 (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.
For fresh femoral neck fracture internal fixation, both DHS and CCS can make strong fixation of hip and have good recovery. There is no statistical difference in complications after surgery between the two procedures. Patients with DHS internal fixation have earlier postoperative weight bearing, which is conducive to functional exercise of the injured limb. DHS internal fixation system is recommended for patients with unstable fractures and severe osteoporosis.
Detailed description
Objective: To compare the clinical effect of dynamic hip screw (DHS) and cannulated compression screw (CCS) in the treatment of fresh femoral neck fracture. Methods: A retrospective study was conducted to analyze the data of 91 patients with fresh femoral neck fracture treated with DHS or CCS in our hospital from January 2012 to June 2016.The cases were divided into two groups according to internal fixation: 44 cases in the DHS group and 47 cases in the CCS group. By comparing operative time, intraoperative bleeding, postoperative load, Harris scoring and the complications such as postoperative necrosis of femoral head and shortening of femoral neck appearance, we evaluated the clinical curative effect of two kinds of fixation.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dynamic hip screw (DHS) | Experimental | Device: internal fixation implantation of dynamic hip screw |
| Cannulated compression screw (CCS) | Active comparator | Device: internal fixation implantation of cannulated compression screw |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- fresh femoral neck fracture
- can walk before fracture
- less than 65 years old
Key exclusion criteria (8 listed)
- Patients combined with other bone fractures.
- Pathological fracture (e.g., primary or metastatic tumor)
- Serious soft tissue injury, judged by the investigator, will impact the union of the fracture, combined open fractures, vascular injury, and combined osteofascial compartment syndrome.
- Multiple systemic injuries judged by researchers not suitable for enrollment. Revision surgeries (for example, due to malunion, nonunion or infection)
- Concurrent medical conditions judged by researchers not suitable for enrollment, such as: metabolic bone disease, post-polio syndrome, poor bone quality, prior history of poor fracture healing, 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 |
|---|---|---|
| internal fixation implantation of dynamic hip screwDynamic hip screws (DHS) are a femoral head-sparing orthopedic device used to treat femoral neck fractures. | Device | Dynamic hip screw (DHS) |
| internal fixation implantation of cannulated compression screwCannulated Screw is designed to provide a minimally invasive method of anatomical fixation. | Device | Cannulated compression screw (CCS) |
Primary outcome
Internal fixation failure rate
Time frame: from operation to 1-year follow-up after the surgery
defined as the total incidence of internal plant cut-out and fracture.
7 secondary outcomes
Number of Participants with Bone nonunion
Time frame: from operation to 1-year follow-up after the surgery
Harris hip score
Time frame: from operation to 1-year follow-up after the surgery
operation time
Time frame: intraoperation
The times of intraoperative fluoroscopy
Time frame: intraoperation
Number of Participants with Postoperative adverse events
Time frame: from operation to 1-year follow-up after the surgery
Garden index
Time frame: from operation to 1-year follow-up after the surgery
A 12-Item Short-Form Health Survey (SF-12)
Time frame: from operation to 1-year follow-up after the surgery
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 13 Jul 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing internal fixation implantation of dynamic hip screw and internal fixation implantation of cannulated compression screw in people with Femoral Neck Fractures, run by Peking University Third 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 3 inclusion and 8 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 13 Jul 2021. 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. 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?
Internal fixation failure rate (time frame: from operation to 1-year follow-up after the surgery). 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 13 Jul 2021.