Closed Fracture of FingerCKFPFFNCT03031015
Cemented K-wire Fixation vs Plating for Finger Fractures
A study testing Cemented K-wire Fixation and Plating in people with Closed Fracture of Finger and Finger Fracture Open, 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. For comparison, we also included another group of patients who were treated using a mini plate and screw system. Bone healing, range of motion of the fingers, costs of treatments, and patient satisfaction were assessed. 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 Open
- What is being tested?
- Cemented K-wire Fixation and Plating
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 131 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2011to 1 May 2014
- 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 fracture or open injury with small wound less than 1.5 cm;
- involvement of proximal phalanges of index to little fingers; shaft fractures;
- at least 5 mm in length of the most distal and proximal fragments so that the K-wires or screws can be engaged;
- oblique, spiral, and comminuted fractures;
- 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;
- severe open injury or crush injuries; tendon or neurovascular injuries; - involvement of articular surface;
- old fractures exceeding 15 days because close reduction was most likely difficult;
- a combined tendon, nerve, or artery injuries or diseases; 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 of Cemented K-wire Fixation and Plating of Shaft Fractures of Proximal Phalanges
To introduce a novel external-fixation technique using the combination of K-wires and cement. For comparison, we also included another group of patients who were treated using a mini plate and screw system. Bone healing, range of motion of the fingers, costs of treatments, and patient satisfaction were assessed.
Read the detailed description
Shaft fractures of the proximal phalanx are common injuries that may significantly affect hand function. Good fracture stability to allow early mobilization of joints and thus early return of function. The objective of this report is to introduce a novel external-fixation technique using the combination of K-wires and cement. For comparison, we also included another group of patients who were treated using a mini plate and screw system. A total of 104 patients (131 fingers) were randomly allocated into group A (56 patients) and B (51 patients). Patients in group A were treated with cemented K-wire fixation; and patients in group B were treated with conventional mini-plate. Bone healing, range of motion of the fingers, costs of treatments, and patient satisfaction were assessed.
- Conditions
- Closed Fracture of Finger, Finger Fracture Open
- Being tested
- Cemented K-wire Fixation, Plating
- 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-wire FixationDevice
Fractures were reduced and then fixed with cemented K-wires.
PlatingDevice
Fractures were reduced and then fixed with Plate.
| Study group | Role | What they receive |
|---|---|---|
| Cemented K-wire Fixation | Experimental | The mean age of group A was 41 years (range, 18-63 years). There were 56 male and 11 female patients. The mean time from injury to operation was 5±4.53 days. Injured digits included index (n=24), long (n=19), ring (n=9), and little (n=15) fingers. Types of fractures were transversal (n=31), oblique or spiral (n=14), and comminuted (n=22) fractures. The patients were treated with Cemented K-wire Fixation. Receives: Device: Cemented K-wire Fixation; Device: Plating |
| Plating | Active comparator | The mean age of group A was 39 years (range, 19-61 years). There were 51 male and 13 female patients. The mean time from injury to operation was 6±5.53 days. Injured digits included index (n=21), long (n=17), ring (n=10), and little (n=16) fingers. Types of fractures were transversal (n=34), oblique or spiral (n=11), and comminuted (n=19) fractures.The patients were treated with Plating. Receives: Device: Cemented K-wire Fixation; Device: Plating |
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 posted25 Jan 2017 (estimated)
- Study start1 Jan 2011
- Primary completion1 May 2014
- Study completion1 May 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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 proximal phalangeal fractures of fingers.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 131 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Second Hospital of Qinhuangdao
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xu Zhang, MD, Study chair, Third Hospital of Hebei Medical UniversityXinzhong Shao, MD, Principal investigator, Third Hospital of Hebei Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03031015
- Sponsor's protocol ID
- THHMU201701
- Acronym
- CKFPFF
- Status last verified
- Jan 2017
- First submitted
- 19 Jan 2017
- Last updated
- 25 Jan 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
Miller L, Ada L, Crosbie J, Wajon A. Pattern of recovery after open reduction and internal fixation of proximal phalangeal fractures in the finger: a prospective longitudinal study. J Hand Surg Eur Vol. 2017 Feb;42(2):137-143. doi: 10.1177/1753193416670591. Epub 2016 Oct 4.
PubMed 27702779Borbas P, Dreu M, Poggetti A, Calcagni M, Giesen T. Treatment of proximal phalangeal fractures with an antegrade intramedullary screw: a cadaver study. J Hand Surg Eur Vol. 2016 Sep;41(7):683-7. doi: 10.1177/1753193416641319. Epub 2016 Apr 7.
PubMed 27056278Miller L, Crosbie J, Wajon A, Ada L. No difference between two types of exercise after proximal phalangeal fracture fixation: a randomised trial. J Physiother. 2016 Jan;62(1):12-9. doi: 10.1016/j.jphys.2015.11.006. Epub 2015 Dec 14.
PubMed 26699692Zhang X, Yu Y, Shao X, Dhawan V, Du W. A randomized comparison of bone-cement K-wire fixation vs. plate fixation of shaft fractures of proximal phalanges. Phys Sportsmed. 2019 May;47(2):189-198. doi: 10.1080/00913847.2018.1546106. Epub 2018 Nov 14.
PubMed 30408421
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Comparison of Cemented K-wire Fixation and Plating of Shaft Fractures of Proximal Phalanges
- ClinicalTrials.gov ID
- NCT03031015
- Acronym / sponsor ID
- CKFPFF / THHMU201701
- Conditions
- Closed Fracture of Finger, Finger Fracture Open
- Keywords
- Reduction, Fracture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 131 participants (actual)
- Lead sponsor
- The Second Hospital of QinhuangdaoUniversity, hospital or other
- Study start
- 1 Jan 2011 (actual)
- Primary completion
- 1 May 2014 (actual)
- Study completion
- 1 May 2014 (actual)
- First posted
- 25 Jan 2017 (estimated)
- 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. For comparison, we also included another group of patients who were treated using a mini plate and screw system. Bone healing, range of motion of the fingers, costs of treatments, and patient satisfaction were assessed.
Detailed description
Shaft fractures of the proximal phalanx are common injuries that may significantly affect hand function. Good fracture stability to allow early mobilization of joints and thus early return of function. The objective of this report is to introduce a novel external-fixation technique using the combination of K-wires and cement. For comparison, we also included another group of patients who were treated using a mini plate and screw system. A total of 104 patients (131 fingers) were randomly allocated into group A (56 patients) and B (51 patients). Patients in group A were treated with cemented K-wire fixation; and patients in group B were treated with conventional mini-plate. Bone healing, range of motion of the fingers, costs of treatments, and patient satisfaction were assessed.
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 proximal phalangeal fractures of fingers.
| Arm | Type | Receives |
|---|---|---|
| Cemented K-wire Fixation | Experimental | Device: Cemented K-wire Fixation, Device: PlatingThe mean age of group A was 41 years (range, 18-63 years). There were 56 male and 11 female patients. The mean time from injury to operation was 5±4.53 days. Injured digits included index (n=24), long (n=19), ring (n=9), and little (n=15) fingers. Types of fractures were transversal (n=31), oblique or spiral (n=14), and comminuted (n=22) fractures. The patients were treated with Cemented K-wire Fixation. |
| Plating | Active comparator | Device: Cemented K-wire Fixation, Device: PlatingThe mean age of group A was 39 years (range, 19-61 years). There were 51 male and 13 female patients. The mean time from injury to operation was 6±5.53 days. Injured digits included index (n=21), long (n=17), ring (n=10), and little (n=16) fingers. Types of fractures were transversal (n=34), oblique or spiral (n=11), and comminuted (n=19) fractures.The patients were treated with Plating. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- patient aged between 18 and 65 years;
- acute fractures within 15 days;
- closed fracture or open injury with small wound less than 1.5 cm;
- involvement of proximal phalanges of index to little fingers; shaft fractures;
- at least 5 mm in length of the most distal and proximal fragments so that the K-wires or screws can be engaged;
Key exclusion criteria (7 listed)
- patients younger than 18 years are excluded because of skeletal immaturity;
- patients older than 65 years are excluded because of possible osteoporosis;
- severe open injury or crush injuries; tendon or neurovascular injuries; - involvement of articular surface;
- old fractures exceeding 15 days because close reduction was most likely difficult;
- a combined tendon, nerve, or artery injuries or diseases; diabetes, gout, ganglion;
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-wire FixationFractures were reduced and then fixed with cemented K-wires. | Device | Cemented K-wire Fixation, Plating |
| PlatingFractures were reduced and then fixed with Plate. | Device | Cemented K-wire Fixation, Plating |
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 25 Jan 2017.
- Results publication: PubMed 27702779Miller L, Ada L, Crosbie J, Wajon A. Pattern of recovery after open reduction and internal fixation of proximal phalangeal fractures in the finger: a prospective longitudinal study. J Hand Surg Eur Vol. 2017 Feb;42(2):137-143. doi: 10.1177/1753193416670591. Epub 2016 Oct 4.
- Results publication: PubMed 27056278Borbas P, Dreu M, Poggetti A, Calcagni M, Giesen T. Treatment of proximal phalangeal fractures with an antegrade intramedullary screw: a cadaver study. J Hand Surg Eur Vol. 2016 Sep;41(7):683-7. doi: 10.1177/1753193416641319. Epub 2016 Apr 7.
- Results publication: PubMed 26699692Miller L, Crosbie J, Wajon A, Ada L. No difference between two types of exercise after proximal phalangeal fracture fixation: a randomised trial. J Physiother. 2016 Jan;62(1):12-9. doi: 10.1016/j.jphys.2015.11.006. Epub 2015 Dec 14.
- Derived from this study: PubMed 30408421Zhang X, Yu Y, Shao X, Dhawan V, Du W. A randomized comparison of bone-cement K-wire fixation vs. plate fixation of shaft fractures of proximal phalanges. Phys Sportsmed. 2019 May;47(2):189-198. doi: 10.1080/00913847.2018.1546106. Epub 2018 Nov 14.
- 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.
Xu Zhang, MD study chair
Third Hospital of Hebei Medical University
Xinzhong Shao, MD principal investigator
Third Hospital of Hebei Medical University
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 Fixation and Plating in people with Closed Fracture of Finger and Finger Fracture Open, 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 7 inclusion and 7 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 25 Jan 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 NCT03031015, which also lists 4 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 25 Jan 2017.