Closed Fracture of FingerNCT03082872
Cemented K-wire Fixation vs Open Transfixion Pinning
A study testing Cemented K-wire and Transfixion Pinning in people with Closed Fracture of Finger and Finger Fracture, run by The Second Hospital of Qinhuangdao at 1 site in China.
Trial summary
To introduce a novel external-fixation technique using the combination of K-wires and cement, and the objective of this report is also to compare the technique with conventional open transfixion pinning. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Closed Fracture of Finger, Finger Fracture
- What is being tested?
- Cemented K-wire and Transfixion Pinning
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2009to 30 Jan 2015
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patient aged between 18 and 65 years;
- acute fractures within 15 days;
- closed fractures or fractures with small open wound less than 1.5 cm;
- involvement of single middle phalanges of index to little fingers;
- shaft fractures; at least 5 mm in length of the most distal and proximal fragments so that K-wires can be secured;
- transversal, short oblique or spiral fractures;
- comminuted fractures of middle third phalanx;
- normal opposite hand for comparison.
Who cannot join
- patients younger than 18 years are excluded because of skeletal immaturity;
- patients older than 65 years are excluded because of possible osteoporosis;
- multiple finger involvement; severe open injury or crush injuries;
- combined tendon or neurovascular injuries; involvement of articular surface;
- old fractures exceeding 15 days because close reduction most likely became difficult;
- combined tendon, nerve, or artery injuries or diseases;
Show all 9Show fewer
- diabetes, gout, ganglion;
- osseous tumors, and other disease affecting bony structures and joint motion;
- patients who declined to participate.
Trial locations and contacts
1 site in 1 country.
China1 site
Third Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050051
About this study
Official title: Randomized Comparison Between Cemented K-wire Fixation vs Open Transfixion Pinning for the Treatment of Shaft Fractures of Middle Phalanges
To introduce a novel external-fixation technique using the combination of K-wires and cement, and the objective of this report is also to compare the technique with conventional open transfixion pinning.
Read the detailed description
Shaft fractures of the middle phalanx are common injuries that are often difficult to treat. Currently, fracture fixation is usually achieved by using K-wire, but pin configurations are controversial.The objective of this report is to introduce treatment of shaft fractures of middle phalanx with a novel external-fixation technique using combined K-wires and cement. For comparison, we also included another group of patients who were treated using open transfixion pinning.A total of 98 patients (98 fingers) with shaft fractures of middle phalanx were randomly allocated to group A (n=51) and B (n=47). Fingers in group A were treated with cemented K-wire fixation, and fingers in group B were treated using conventional open transfixion pinning. Time of bone healing, range of motion of the fingers, and joint motion were assessed. A p<0.05 was considered statistically significant.
- Conditions
- Closed Fracture of Finger, Finger Fracture
- Being tested
- Cemented K-wire, Transfixion Pinning
- Keywords
- Reduction, Fracture
- Medical subject headings
- Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cemented K-wireDevice
Fracture of proximal phalanx was treated with Cemented K-wire.
Transfixion PinningDevice
Fracture of proximal phalanx was treated with transfixion pinning.
| Study group | Role | What they receive |
|---|---|---|
| Cemented K-wire Fixation | Experimental | Fractures were transverse (n=32), short oblique or spiral (n=5), and comminuted (n=14) fractures. Receives: Device: Cemented K-wire; Device: Transfixion Pinning |
| Open Transfixion Pinning | Experimental | Fractures were transverse (n=28), short oblique or spiral (n=4), and comminuted (n=15) fractures. Receives: Device: Cemented K-wire; Device: Transfixion Pinning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone healing
Time of bone healing
Measured: Up to 12 weeks. From date of randomization until the date of first documented progression from any cause, which is assessed up to 12 weeks.
Secondary outcomes (1)
Joint motion
Range of motion of MCP, PIP, and DIP joints
Measured: Up to 2 years. From date of randomization until the date of second documented progression from any cause, which is assessed up to 2 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2017
- Study start1 Jan 2009
- Primary completion30 Jan 2015
- Study completion30 Jan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Closed Fracture of FingerStudies 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
- Model description
- Patients with middle proximal fractures of fingers
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Second Hospital of Qinhuangdao
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03082872
- Sponsor's protocol ID
- THHMU201763
- Status last verified
- Mar 2017
- First submitted
- 7 Mar 2017
- Last updated
- 17 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to share the IPD data
Publications
Edwards GS Jr, O'Brien ET, Heckman MM. Retrograde cross-pinning of transverse metacarpal and phalangeal fractures. Hand. 1982 Jun;14(2):141-8. doi: 10.1016/s0072-968x(82)80005-3. No abstract available.
PubMed 7117927Margic K. External fixation of closed metacarpal and phalangeal fractures of digits. A prospective study of one hundred consecutive patients. J Hand Surg Br. 2006 Feb;31(1):30-40. doi: 10.1016/j.jhsb.2005.09.013. Epub 2005 Nov 15.
PubMed 16293357Gaston RG, Chadderdon C. Phalangeal fractures: displaced/nondisplaced. Hand Clin. 2012 Aug;28(3):395-401, x. doi: 10.1016/j.hcl.2012.05.032. Epub 2012 Jun 26.
PubMed 22883890
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Comparison Between Cemented K-wire Fixation vs Open Transfixion Pinning for the Treatment of Shaft Fractures of Middle Phalanges
- ClinicalTrials.gov ID
- NCT03082872
- Acronym / sponsor ID
- THHMU201763
- Conditions
- Closed Fracture of Finger, Finger Fracture
- Keywords
- Reduction, Fracture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- The Second Hospital of QinhuangdaoUniversity, hospital or other
- Study start
- 1 Jan 2009 (actual)
- Primary completion
- 30 Jan 2015 (actual)
- Study completion
- 30 Jan 2015 (actual)
- First posted
- 17 Mar 2017 (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.
To introduce a novel external-fixation technique using the combination of K-wires and cement, and the objective of this report is also to compare the technique with conventional open transfixion pinning.
Detailed description
Shaft fractures of the middle phalanx are common injuries that are often difficult to treat. Currently, fracture fixation is usually achieved by using K-wire, but pin configurations are controversial.The objective of this report is to introduce treatment of shaft fractures of middle phalanx with a novel external-fixation technique using combined K-wires and cement. For comparison, we also included another group of patients who were treated using open transfixion pinning.A total of 98 patients (98 fingers) with shaft fractures of middle phalanx were randomly allocated to group A (n=51) and B (n=47). Fingers in group A were treated with cemented K-wire fixation, and fingers in group B were treated using conventional open transfixion pinning. Time of bone healing, range of motion of the fingers, and joint motion were assessed. A p<0.05 was considered statistically significant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Patients with middle proximal fractures of fingers
| Arm | Type | Receives |
|---|---|---|
| Cemented K-wire Fixation | Experimental | Device: Cemented K-wire, Device: Transfixion PinningFractures were transverse (n=32), short oblique or spiral (n=5), and comminuted (n=14) fractures. |
| Open Transfixion Pinning | Experimental | Device: Cemented K-wire, Device: Transfixion PinningFractures were transverse (n=28), short oblique or spiral (n=4), and comminuted (n=15) fractures. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- patient aged between 18 and 65 years;
- acute fractures within 15 days;
- closed fractures or fractures with small open wound less than 1.5 cm;
- involvement of single middle phalanges of index to little fingers;
- shaft fractures; at least 5 mm in length of the most distal and proximal fragments so that K-wires can be secured;
Key exclusion criteria (9 listed)
- patients younger than 18 years are excluded because of skeletal immaturity;
- patients older than 65 years are excluded because of possible osteoporosis;
- multiple finger involvement; severe open injury or crush injuries;
- combined tendon or neurovascular injuries; involvement of articular surface;
- old fractures exceeding 15 days because close reduction most likely became difficult;
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 |
|---|---|---|
| Cemented K-wireFracture of proximal phalanx was treated with Cemented K-wire. | Device | Cemented K-wire Fixation, Open Transfixion Pinning |
| Transfixion PinningFracture of proximal phalanx was treated with transfixion pinning. | Device | Cemented K-wire Fixation, Open Transfixion Pinning |
Primary outcome
Bone healing
Time frame: Up to 12 weeks. From date of randomization until the date of first documented progression from any cause, which is assessed up to 12 weeks.
Time of bone healing
1 secondary outcome
Joint motion
Time frame: Up to 2 years. From date of randomization until the date of second documented progression from any cause, which is assessed up to 2 years.
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 17 Mar 2017.
- Results publication: PubMed 7117927Edwards GS Jr, O'Brien ET, Heckman MM. Retrograde cross-pinning of transverse metacarpal and phalangeal fractures. Hand. 1982 Jun;14(2):141-8. doi: 10.1016/s0072-968x(82)80005-3. No abstract available.
- Results publication: PubMed 16293357Margic K. External fixation of closed metacarpal and phalangeal fractures of digits. A prospective study of one hundred consecutive patients. J Hand Surg Br. 2006 Feb;31(1):30-40. doi: 10.1016/j.jhsb.2005.09.013. Epub 2005 Nov 15.
- Results publication: PubMed 22883890Gaston RG, Chadderdon C. Phalangeal fractures: displaced/nondisplaced. Hand Clin. 2012 Aug;28(3):395-401, x. doi: 10.1016/j.hcl.2012.05.032. Epub 2012 Jun 26.
- Individual participant dataSharing planned: No. No plan to share the IPD data
Related trials for Closed Fracture of Finger
Recruiting
Casting Versus Percutaneus Pinning Treatment of Pediatric Overriding Distal Forearm Fractures
Pediatric Overriding Distal Metaphyseal Radius Fractures
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 Cemented K-wire and Transfixion Pinning in people with Closed Fracture of Finger and Finger Fracture, run by The Second Hospital of Qinhuangdao 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 8 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: finished, as of the sponsor's last update on 17 Mar 2017. 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?
Bone healing (time frame: Up to 12 weeks. From date of randomization until the date of first documented progression from any cause, which is assessed up to 12 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03082872, which also lists 3 linked publications.
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 17 Mar 2017.