Clavicle InjuriesNCT01555372
Treatment of Unstable Distal Clavicular Fractures (Neer 2b): Hook Plate vs Locking Plate
A study testing Hook Plate and Locking Plate in people with Clavicle Injuries, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
The investigators propose to test the hypotheses that compared with Hook Plate (HP), Locking Plate (LP) reduces the postoperative complications and leads to a better functional recovery after unstable distal clavicle fractures (Neer 2b). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Clavicle Injuries
- What is being tested?
- Hook Plate and Locking Plate
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- May 2012to 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-80 years
- Unstable fractures of distal clavicle (Neer 2b fractures), acute or chronic and unilateral fractures.
- Normal shoulder functions before injury.
- Internal fixation with either HP or LP.
- The subjects were in good health and were able to comply with all prescribed follow-up procedures.
Who cannot join
- Patients who present multiple traumas.
- Patients with other serious injuries to either upper limb that would interfere with rehabilitation.
- Patients with a pathological, recurrent or open clavicle fracture.
- Patient unwilling to give written informed consent.
- Patients with cognitive impairment unable to comply with treatment programme.
- Patients with a serious disorder of bone metabolism other than osteoporosis (e.g., endocrine bone diseases, osteomalacia and Paget's disease)
Trial locations and contacts
1 site in 1 country.
China1 site
Orthopaedic department,Xinhua hospital affiliated to Shanghai JiaoTong University School of Medicine
Shanghai, 200092
Jiang L sheng, doctor, 008613002195209, jiangleisheng@126.com
Yang Y hua, master, 008613402013616, yuesjtu@126.com
About this study
The investigators propose to test the hypotheses that compared with Hook Plate (HP), Locking Plate (LP) reduces the postoperative complications and leads to a better functional recovery after unstable distal clavicle fractures (Neer 2b).
Read the detailed description
Controversy exists regarding the optimal treatment for patients with unstable distal clavicular fractures (Neer 2b). The recognized treatment alternatives are Hook plate.Notably, criticisms on this fixation method also appeared and the potential risks of hook migration, loosening, subacromial impingement or rotator cuff injury, and acromial osteolysis were still unsolved. Recently, Herrmann et al.and Largo et al.stabilized the distal clavicle with Locking plate (LP) and these studies offered encouraging support for LP. Because of small sample size (27 patients) and nonrandomization, the convictive power of these researches is not strong enough.
- Conditions
- Clavicle Injuries
- Being tested
- Hook Plate, Locking Plate
- Keywords
- unstable distal clavicular fractures (Neer 2b), Study Protocol, Fracture Fixation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hook PlateDevice
All participants will have an open reduction internal fixation. The affected upper limb will be temporarily fixed by a sling after admission. Under necessary test, general anaesthetic and antibiotic prophylaxis, the patients will be placed in a beach-chair position in an orthopaedic theatre. The operated side will be prepped and draped and a transverse incision will be made over the fracture site. The fracture ends will be identified, reduced and fixed with HP. X-ray was applied to check the grade of reduction before the operation is completed. Post-operative care will include early active mobilization managed by a standard physiotherapy rehabilitation regime.
Locking PlateDevice
All participants will have an open reduction internal fixation. The affected upper limb will be temporarily fixed by a sling after admission. Under necessary test, general anaesthetic and antibiotic prophylaxis, the patients will be placed in a beach-chair position in an orthopaedic theatre. The operated side will be prepped and draped and a transverse incision will be made over the fracture site. The fracture ends will be identified, reduced and fixed with locking plate. X-ray was applied to check the grade of reduction before the operation is completed. Post-operative care will include early active mobilization managed by a standard physiotherapy rehabilitation regime.
| Study group | Role | What they receive |
|---|---|---|
| Hook Plate | Active comparator | 20 participants will be enrolled in this group. Receives: Device: Hook Plate |
| Locking Plates | Experimental | 20 paticipants will be enrolled in this group Receives: Device: Locking Plate |
What is being measured
The primary outcome is the main question the study is designed to answer.
the postoperative complications
complication that related with surgery or fracture will be defined as any event that necessitated another operative procedure or additional medical treatment
Measured: 12 months
Secondary outcomes (1)
the affected limb function
the affected limb function measured using the Constant-Murley Score and using the Disabilities of the Arm, Shoulder and Hand (DASH) Score measured at 3, 6,9and 12months post-operatively.
Measured: 3, 6, 9,12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2012 (estimated)
- Study startMay 2012
- Primary completionMay 2013 (estimated)
- Study completionMay 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clavicle InjuriesStudies of the same condition, open and under way.
- More trials run by Shanghai Jiao Tong University School of MedicineThe 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Nanjing Medical University, The First People's Hospital of Huzhou, Huai'an No. 2 People's Hospital, The First Affiliated Hospital of Nanchang University
- Responsible party
- Principal investigator, Leisheng Jiang, Shanghai Jiao Tong University School of Medicine
- Investigators
- Sheng L Jiang, doctor, Study chair, Orthopaedic department, Shanghai Jiaotong University Xinhua Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01555372
- Sponsor's protocol ID
- U2032001
- Status last verified
- Mar 2012
- First submitted
- 11 Mar 2012
- Last updated
- 15 Mar 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Unstable Distal Clavicular Fractures (Neer 2b): Hook Plate vs Locking Plate
- ClinicalTrials.gov ID
- NCT01555372
- Acronym / sponsor ID
- U2032001
- Conditions
- Clavicle Injuries
- Keywords
- unstable distal clavicular fractures (Neer 2b), Study Protocol, Fracture Fixation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Collaborators
- Nanjing Medical University, The First People's Hospital of Huzhou, Huai'an No. 2 People's Hospital, The First Affiliated Hospital of Nanchang University
- Study start
- May 2012
- Primary completion
- May 2013 (estimated)
- Study completion
- May 2014 (estimated)
- First posted
- 15 Mar 2012 (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 investigators propose to test the hypotheses that compared with Hook Plate (HP), Locking Plate (LP) reduces the postoperative complications and leads to a better functional recovery after unstable distal clavicle fractures (Neer 2b).
Detailed description
Controversy exists regarding the optimal treatment for patients with unstable distal clavicular fractures (Neer 2b). The recognized treatment alternatives are Hook plate.Notably, criticisms on this fixation method also appeared and the potential risks of hook migration, loosening, subacromial impingement or rotator cuff injury, and acromial osteolysis were still unsolved. Recently, Herrmann et al.and Largo et al.stabilized the distal clavicle with Locking plate (LP) and these studies offered encouraging support for LP. Because of small sample size (27 patients) and nonrandomization, the convictive power of these researches is not strong enough.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hook Plate | Active comparator | Device: Hook Plate20 participants will be enrolled in this group. |
| Locking Plates | Experimental | Device: Locking Plate20 paticipants will be enrolled in this group |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18-80 years
- Unstable fractures of distal clavicle (Neer 2b fractures), acute or chronic and unilateral fractures.
- Normal shoulder functions before injury.
- Internal fixation with either HP or LP.
- The subjects were in good health and were able to comply with all prescribed follow-up procedures.
Key exclusion criteria (6 listed)
- Patients who present multiple traumas.
- Patients with other serious injuries to either upper limb that would interfere with rehabilitation.
- Patients with a pathological, recurrent or open clavicle fracture.
- Patient unwilling to give written informed consent.
- Patients with cognitive impairment unable to comply with treatment programme.
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 |
|---|---|---|
| Hook PlateAll participants will have an open reduction internal fixation. The affected upper limb will be temporarily fixed by a sling after admission. Under necessary test, general anaesthetic and antibiotic prophylaxis, the patients will be placed in a beach-chair position in an orthopaedic theatre. The operated side will be prepped and draped and a transverse incision will be made over the fracture site. The fracture ends will be identified, reduced and fixed with HP. X-ray was applied to check the grade of reduction before the operation is completed. Post-operative care will include early active mobilization managed by a standard physiotherapy rehabilitation regime. | Device | Hook Plate |
| Locking PlateAll participants will have an open reduction internal fixation. The affected upper limb will be temporarily fixed by a sling after admission. Under necessary test, general anaesthetic and antibiotic prophylaxis, the patients will be placed in a beach-chair position in an orthopaedic theatre. The operated side will be prepped and draped and a transverse incision will be made over the fracture site. The fracture ends will be identified, reduced and fixed with locking plate. X-ray was applied to check the grade of reduction before the operation is completed. Post-operative care will include early active mobilization managed by a standard physiotherapy rehabilitation regime. | Device | Locking Plates |
Primary outcome
the postoperative complications
Time frame: 12 months
complication that related with surgery or fracture will be defined as any event that necessitated another operative procedure or additional medical treatment
1 secondary outcome
the affected limb function
Time frame: 3, 6, 9,12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2012.
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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.
Sheng L Jiang, doctor study chair
Orthopaedic department, Shanghai Jiaotong University Xinhua Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hook Plate and Locking Plate in people with Clavicle Injuries, run by Shanghai Jiao Tong University School of Medicine 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 5 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: status not confirmed, as of the sponsor's last update on 15 Mar 2012. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jiang L sheng, doctor (008613002195209, jiangleisheng@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the postoperative complications (time frame: 12 months). 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 15 Mar 2012.