Closed Frykman Type II Fracture of Right Radial HeadNCT02410070
A Comparison of Minimal Approach With Conventional Approach for Distal Radial Fractures
A study testing Incision in people with Closed Frykman Type II Fracture of Right Radial Head, run by The Second Hospital of Qinhuangdao.
Trial summary
The objective of this study is to compare a minimal invasive approach with the conventional flexor carpi radialis approach for volar plating of distal radial fractures. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Closed Frykman Type II Fracture of Right Radial Head
- What is being tested?
- Incision
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 157 participants
- Where
- No sites listed yet
- Study dates
- Jan 2011to Feb 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Fernandez type II-IV radial fractures.
Who cannot join
- Fernandez type I radial fracture.
- Fernandez type V radial fracture.
- Open radial fractures.
- Surgery using K-wires or screws alone.
- The use of external fixators.
- multiple fractures, pathological fracture.
About this study
The objective of this study is to compare a minimal invasive approach with the conventional flexor carpi radialis approach for volar plating of distal radial fractures.
Read the detailed description
The objective of this study is to compare a minimal invasive approach with the conventional flexor carpi radialis approach for volar plating of distal radial fractures.
From January 2011 to September 2012, 157 patients with distal radial fractures were allocated into group A (n=83) and B (n=74). Patients in group A were treated through a 1.5 to 2-cm long incision, and patients in group B were treated through the conventional flexor carpi radialis approach. All fractures were fixed with volar plates. Patients were assessed range of motion of the wrist, grip strength of the hand, and pronation strength of the wrist. Results were analyzed with the Statistical Package for Social Sciences 13.0. A P < 0.05 was statistically significant.
- Being tested
- Incision
- Keywords
- Distal radial fracture, pronator quadratus, mini-approach, volar plating, open reduction and internal fixation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IncisionProcedure or surgery
The objective of this report is to compare a minimal invasive approach with the conventional flexor carpi radialis approach for volar plating of distal radial fractures.
| Study group | Role | What they receive |
|---|---|---|
| Though Volar Minimal Incision | Experimental | Patients in group A were treated through a small Incision. Receives: Procedure: Incision |
| Though Convectional Incision | Active comparator | Patients in group B were treated through the conventional Incision Receives: Procedure: Incision |
What is being measured
The primary outcome is the main question the study is designed to answer.
range of motion of the wrist
measurement of range of motion of the wrist with a goniometer, at 2 years follow-up.
Measured: 2 years
Secondary outcomes (2)
grip strength of the hand
Assessment of grip strength of the hand using a Baseline hydraulic hand dynamometer, at 2 years follow-up.
Measured: 2 years
pronation strength of the forearm
Isometric testing of pronation torque, McConkey method at 5 positions of rotation (90° of supination, 45° of supination, neutral, 45° of pronation, and 80° of pronation) , at 2 years follow-up.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2015 (estimated)
- Study startJan 2011
- Primary completionDec 2014
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Closed Frykman Type II Fracture of Right Radial HeadStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 157 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, The Second Hospital of Qinhunangdao
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02410070
- Sponsor's protocol ID
- 1011126
- Status last verified
- Mar 2015
- First submitted
- 18 Mar 2015
- Last updated
- 7 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Skouras E, Hosseini Y, Berger V, Wegmann K, Koslowsky TC. Operative treatment and outcome of unstable distal radial fractures using a palmar T-miniplate at a non-specialized institution. Strategies Trauma Limb Reconstr. 2013 Nov;8(3):155-60. doi: 10.1007/s11751-013-0170-y. Epub 2013 Aug 6.
PubMed 23918414Protopsaltis TS, Ruch DS. Volar approach to distal radius fractures. J Hand Surg Am. 2008 Jul-Aug;33(6):958-65. doi: 10.1016/j.jhsa.2008.04.018.
PubMed 18656773
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Minimal Approach With Conventional Approach for Distal Radial Fractures
- ClinicalTrials.gov ID
- NCT02410070
- Acronym / sponsor ID
- 1011126
- Keywords
- Distal radial fracture, pronator quadratus, mini-approach, volar plating, open reduction and internal fixation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 157 participants (actual)
- Lead sponsor
- The Second Hospital of QinhuangdaoUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Dec 2014 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 7 Apr 2015 (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.
The objective of this study is to compare a minimal invasive approach with the conventional flexor carpi radialis approach for volar plating of distal radial fractures.
Detailed description
The objective of this study is to compare a minimal invasive approach with the conventional flexor carpi radialis approach for volar plating of distal radial fractures.
From January 2011 to September 2012, 157 patients with distal radial fractures were allocated into group A (n=83) and B (n=74). Patients in group A were treated through a 1.5 to 2-cm long incision, and patients in group B were treated through the conventional flexor carpi radialis approach. All fractures were fixed with volar plates. Patients were assessed range of motion of the wrist, grip strength of the hand, and pronation strength of the wrist. Results were analyzed with the Statistical Package for Social Sciences 13.0. A P < 0.05 was statistically significant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Though Volar Minimal Incision | Experimental | Procedure: IncisionPatients in group A were treated through a small Incision. |
| Though Convectional Incision | Active comparator | Procedure: IncisionPatients in group B were treated through the conventional Incision |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Fernandez type II-IV radial fractures.
Key exclusion criteria (6 listed)
- Fernandez type I radial fracture.
- Fernandez type V radial fracture.
- Open radial fractures.
- Surgery using K-wires or screws alone.
- The use of external fixators.
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 |
|---|---|---|
| IncisionThe objective of this report is to compare a minimal invasive approach with the conventional flexor carpi radialis approach for volar plating of distal radial fractures. | Procedure or surgery | Though Convectional Incision, Though Volar Minimal Incision |
Primary outcome
range of motion of the wrist
Time frame: 2 years
measurement of range of motion of the wrist with a goniometer, at 2 years follow-up.
2 secondary outcomes
grip strength of the hand
Time frame: 2 years
pronation strength of the forearm
Time frame: 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 7 Apr 2015.
- Results publication: PubMed 23918414Skouras E, Hosseini Y, Berger V, Wegmann K, Koslowsky TC. Operative treatment and outcome of unstable distal radial fractures using a palmar T-miniplate at a non-specialized institution. Strategies Trauma Limb Reconstr. 2013 Nov;8(3):155-60. doi: 10.1007/s11751-013-0170-y. Epub 2013 Aug 6.
- Results publication: PubMed 18656773Protopsaltis TS, Ruch DS. Volar approach to distal radius fractures. J Hand Surg Am. 2008 Jul-Aug;33(6):958-65. doi: 10.1016/j.jhsa.2008.04.018.
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
The Second Hospital of Qinhunangdao
Questions about this trial
What is this clinical trial studying?
A study testing Incision in people with Closed Frykman Type II Fracture of Right Radial Head, run by The Second Hospital of Qinhuangdao.
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 1 inclusion and 6 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 7 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
range of motion of the wrist (time frame: 2 years). 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 NCT02410070, which also lists 2 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 7 Apr 2015.