Fracture ClavicleNCT03773848
Hook Plate vs Tightrope in Fixation of Fracture Distal Third Clavicle
A study testing Open Reduction Internal Fixation (ORIF) in people with Fracture Clavicle, run by Assiut University.
Trial summary
to compare the clinical \& radiological outcomes of hook plate \& tightrope fixation in fracture of lateral third clavicle. Read more about this study
- Who is it for?
- Ages 16 to 80 years
- Conditions the study is for
- Fracture Clavicle
- What is being tested?
- Open Reduction Internal Fixation (ORIF)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2019to 1 Feb 2021
- 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 16 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Adults (over 16 years old) including both sexes.
- Acute fractures within 3 weeks of injury.
- Isolated \& closed fractures.
Who cannot join
- Pathological fracture of distal clavicle.
- Deteriorated general health.
- Previous history of dysfunction with the affected shoulder.
- Incomplete medical records or lost to follow up.
Trial locations and contacts
No sites are listed yet.
About this study
to compare the clinical \& radiological outcomes of hook plate \& tightrope fixation in fracture of lateral third clavicle.
Read the detailed description
Adult clavicle fractures account for 4% to 10% of fractures. Distal clavicle fractures occurs in 25% to 30% of all clavicle fracture.The management of fractures of the distal clavicle has been a matter of debate in literature. Neer in 1968 suggested a new classification and proposed general treatment guidelines . Type I and type III fractures are generally treated non-operatively. For type II fractures, surgical management is the treatment of choice .There are numerous operative techniques reported in the past. The methods of surgical treatment could be summarised as follows:
- Fixation in terms of K-wires and different pins such as the Steinmann pin, and Knowles pin. This fixation could also be augmented with concomitant tension band wires
- Coracoclavicular indirect fixation with the use of screws, suture anchors, Dacron graft or Mersilene tape
- Open reduction and clavicular plate fixation with the use of different plate systems such as the Balser plate,locked plate,hook plate, etc.
Different surgical techniques have their own advantages and disadvantages With more than 20 techniques described so far, no single fixation is ideal and perfect. There is still no consensus regarding the best surgical method to fix these fracture ,the investigators choose two of the most common of these methods and evaluate \& compare best radiological \& clinical outcomes of both.
- Conditions
- Fracture Clavicle
- Being tested
- Open Reduction Internal Fixation (ORIF)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Open Reduction Internal Fixation (ORIF)Procedure or surgery
Open Reduction Internal Fixation (ORIF) of fracture lateral third clavicle by hook plate \& tightrope
| Study group | Role | What they receive |
|---|---|---|
| A- hook plate | Experimental | All participants will have an Open Reduction Internal Fixation (ORIF). The affected upper limb will be temporarily fixed by a sling after admission. 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 hook plate. X-ray was applied to check the grade of reduction before the operation is completed. Receives: Procedure: Open Reduction Internal Fixation (ORIF) |
| B- tightrope | Experimental | All participants will have an Open Reduction Internal Fixation (ORIF). The affected upper limb will be temporarily fixed by a sling after admission. 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 tightrope. X-ray was applied to check the grade of reduction before the operation is completed. Receives: Procedure: Open Reduction Internal Fixation (ORIF) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of limb function this change will be assessed using Disabilities of the Arm, Shoulder and Hand (DASH) Score as limb function will be expected of some movement limitation at 6 weeks and no limitations to be at 6 months
The DASH is a self-administered questionnaire that consists of thirty core questions and an optional additional eight questions assessing work and sports and/or performing arts activities. Each individual item is scored on a 5-point Likert scale, with lower scores correlating to minimal impairment and higher scores indicating more impairment. The cumulative DASH score is scaled from 0 to 100, with higher scores indicating more disability
Measured: at 6 weeks & 6 months post-operatively.
Secondary outcomes (4)
Fracture Healing
Radiological evaluation of the fracture by using antero-posterior and axillary views x-ray
Measured: at 6 weeks & 6 months post-operatively.
Blood loss
Recording of the blood loss amount during surgery in milliliters.
Measured: Intra-operatively
Radiation time
Calculation of the exposure time to radiations during surgery in minutes.
Measured: Intra-operatively
Skin condition
Evaluation of skin condition of the surgical incision by clinical inspection
Measured: at 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2018
- Study start1 Jun 2019 (estimated)
- Primary completion1 Jan 2021 (estimated)
- Study completion1 Feb 2021 (estimated)
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 Fracture ClavicleStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Mounir Kamal Ibrahim, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03773848
- Sponsor's protocol ID
- Hook plate vs Tightrope
- Status last verified
- Feb 2019
- First submitted
- 10 Dec 2018
- Last updated
- 21 Feb 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Flinkkila T, Heikkila A, Sirnio K, Pakarinen H. TightRope versus clavicular hook plate fixation for unstable distal clavicular fractures. Eur J Orthop Surg Traumatol. 2015 Apr;25(3):465-9. doi: 10.1007/s00590-014-1526-9. Epub 2014 Sep 9.
PubMed 25200315Haque S, Khan A, Sharma A, Sundararajan S. Technical tip: tightrope fixation of neer type II distal clavicle fracture supported by a case series. Pol Orthop Traumatol. 2014 Mar 27;79:19-22.
PubMed 24675020Lee W, Choi CH, Choi YR, Lim KH, Chun YM. Clavicle hook plate fixation for distal-third clavicle fracture (Neer type II): comparison of clinical and radiologic outcomes between Neer types IIA and IIB. J Shoulder Elbow Surg. 2017 Jul;26(7):1210-1215. doi: 10.1016/j.jse.2016.11.046. Epub 2017 Jan 26.
PubMed 28131682Yan HW, Li L, Wang RC, Yang Y, Xie Y, Tang J, Shi ZY. Clinical efficacies of coracoclavicular ligament reconstruction using suture anchor versus hook plate in the treatment of distal clavicle fracture. Orthop Traumatol Surg Res. 2017 Dec;103(8):1287-1293. doi: 10.1016/j.otsr.2017.07.006. Epub 2017 Aug 8.
PubMed 28801112
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hook Plate vs Tightrope in Fixation of Fracture Distal Third Clavicle
- ClinicalTrials.gov ID
- NCT03773848
- Acronym / sponsor ID
- Hook plate vs Tightrope
- Conditions
- Fracture Clavicle
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jun 2019 (estimated)
- Primary completion
- 1 Jan 2021 (estimated)
- Study completion
- 1 Feb 2021 (estimated)
- First posted
- 12 Dec 2018 (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 compare the clinical \& radiological outcomes of hook plate \& tightrope fixation in fracture of lateral third clavicle.
Detailed description
Adult clavicle fractures account for 4% to 10% of fractures. Distal clavicle fractures occurs in 25% to 30% of all clavicle fracture.The management of fractures of the distal clavicle has been a matter of debate in literature. Neer in 1968 suggested a new classification and proposed general treatment guidelines . Type I and type III fractures are generally treated non-operatively. For type II fractures, surgical management is the treatment of choice .There are numerous operative techniques reported in the past. The methods of surgical treatment could be summarised as follows:
- Fixation in terms of K-wires and different pins such as the Steinmann pin, and Knowles pin. This fixation could also be augmented with concomitant tension band wires
- Coracoclavicular indirect fixation with the use of screws, suture anchors, Dacron graft or Mersilene tape
- Open reduction and clavicular plate fixation with the use of different plate systems such as the Balser plate,locked plate,hook plate, etc.
Different surgical techniques have their own advantages and disadvantages With more than 20 techniques described so far, no single fixation is ideal and perfect. There is still no consensus regarding the best surgical method to fix these fracture ,the investigators choose two of the most common of these methods and evaluate \& compare best radiological \& clinical outcomes of both.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A- hook plate | Experimental | Procedure: Open Reduction Internal Fixation (ORIF)All participants will have an Open Reduction Internal Fixation (ORIF). The affected upper limb will be temporarily fixed by a sling after admission. 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 hook plate. X-ray was applied to check the grade of reduction before the operation is completed. |
| B- tightrope | Experimental | Procedure: Open Reduction Internal Fixation (ORIF)All participants will have an Open Reduction Internal Fixation (ORIF). The affected upper limb will be temporarily fixed by a sling after admission. 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 tightrope. X-ray was applied to check the grade of reduction before the operation is completed. |
Who may qualify
- Ages
- 16 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Adults (over 16 years old) including both sexes.
- Acute fractures within 3 weeks of injury.
- Isolated \& closed fractures.
Key exclusion criteria (4 listed)
- Pathological fracture of distal clavicle.
- Deteriorated general health.
- Previous history of dysfunction with the affected shoulder.
- Incomplete medical records or lost to follow up.
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 |
|---|---|---|
| Open Reduction Internal Fixation (ORIF)Open Reduction Internal Fixation (ORIF) of fracture lateral third clavicle by hook plate \& tightrope | Procedure or surgery | A- hook plate, B- tightrope |
Primary outcome
Improvement of limb function this change will be assessed using Disabilities of the Arm, Shoulder and Hand (DASH) Score as limb function will be expected of some movement limitation at 6 weeks and no limitations to be at 6 months
Time frame: at 6 weeks & 6 months post-operatively.
The DASH is a self-administered questionnaire that consists of thirty core questions and an optional additional eight questions assessing work and sports and/or performing arts activities. Each individual item is scored on a 5-point Likert scale, with lower scores correlating to minimal impairment and higher scores indicating more impairment. The cumulative DASH score is scaled from 0 to 100, with higher scores indicating more disability
4 secondary outcomes
Fracture Healing
Time frame: at 6 weeks & 6 months post-operatively.
Blood loss
Time frame: Intra-operatively
Radiation time
Time frame: Intra-operatively
Skin condition
Time frame: at 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2019.
- Background: PubMed 25200315Flinkkila T, Heikkila A, Sirnio K, Pakarinen H. TightRope versus clavicular hook plate fixation for unstable distal clavicular fractures. Eur J Orthop Surg Traumatol. 2015 Apr;25(3):465-9. doi: 10.1007/s00590-014-1526-9. Epub 2014 Sep 9.
- Background: PubMed 24675020Haque S, Khan A, Sharma A, Sundararajan S. Technical tip: tightrope fixation of neer type II distal clavicle fracture supported by a case series. Pol Orthop Traumatol. 2014 Mar 27;79:19-22.
- Background: PubMed 28131682Lee W, Choi CH, Choi YR, Lim KH, Chun YM. Clavicle hook plate fixation for distal-third clavicle fracture (Neer type II): comparison of clinical and radiologic outcomes between Neer types IIA and IIB. J Shoulder Elbow Surg. 2017 Jul;26(7):1210-1215. doi: 10.1016/j.jse.2016.11.046. Epub 2017 Jan 26.
- Background: PubMed 28801112Yan HW, Li L, Wang RC, Yang Y, Xie Y, Tang J, Shi ZY. Clinical efficacies of coracoclavicular ligament reconstruction using suture anchor versus hook plate in the treatment of distal clavicle fracture. Orthop Traumatol Surg Res. 2017 Dec;103(8):1287-1293. doi: 10.1016/j.otsr.2017.07.006. Epub 2017 Aug 8.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Open Reduction Internal Fixation (ORIF) in people with Fracture Clavicle, run by Assiut University.
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 4 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 21 Feb 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact David (+201221748069, davidmounir1@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement of limb function this change will be assessed using Disabilities of the Arm, Shoulder and Hand (DASH) Score as limb function will be expected of some movement limitation at 6 weeks and no limitations to be at 6 months (time frame: at 6 weeks & 6 months post-operatively.). 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 NCT03773848, 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 21 Feb 2019.