Malunion of Fracture of ClavicleNCT03415958
A Prospective Cohort of Displaced Adolescent Midshaft Clavicle Fractures
An observational study of Malunion of Fracture of Clavicle and Delayed Union of Fracture of Clavicle, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
Trial summary
Outcomes for displaced midshaft clavicle fractures in adolescents are not defined. The current method of treatment for these fractures is non-operative management. There is recent Level 1 evidence in the adult literature to suggest that outcomes are superior when these fractures are managed surgically with open… Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Malunion of Fracture of Clavicle, Delayed Union of Fracture of Clavicle
- How many people
- 49 participants
- Where
- 1 siteCanada
- Study dates
- 28 Mar 2012to 31 Oct 2016
- Phase
- Observational
- 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 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Adolescents (ages 12 to 18) who have a displaced clavicle fracture
Who may be able to join
- Age 12-18 years old
- The only fracture present in that upper extremity
- Individual and/or parents able to comply with follow-up
Who cannot join
- Head injury
- Prior injury, degenerative condition or congenital condition of the upper extremities
- Systemic disease that may impair healing
- Incapable of ensuring follow-up
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Cohort of Displaced Adolescent Midshaft Clavicle Fractures: Are Times to Return to Activities and Functional Outcomes Reasonable for This Population?
Outcomes for displaced midshaft clavicle fractures in adolescents are not defined. The current method of treatment for these fractures is non-operative management. There is recent Level 1 evidence in the adult literature to suggest that outcomes are superior when these fractures are managed surgically with open reduction and internal fixation.
Read the detailed description
The study is a prospective observational cohort design of the natural history of adolescent clavicle fractures treated at the McGill University Health Centre. Surgeon choice will dictate treatment. There is no difference from the current normal therapy choice of each individual surgeon. Patients will be offered either operative or conservative management.
Operative Treatment: Patients with displaced midshaft clavicle fractures will be offered operative treatment which involves open reduction and internal fixation with a plate. This is the standard treatment for completely displaced fractures in the adult population at our Institution based on Level 1 evidence.
Conservative care: Patients will be treated in a sling for the acute phase of two weeks with progressive physiotherapy.
- Keywords
- prospective, adolescent, displaced, clavicle, fracture, mid-shaft
- Medical subject headings
- Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Open reduction internal fixation | Patients with displaced midshaft clavicle fractures will be offered operative treatment which involves open reduction and internal fixation. | |
| Conservative care | Patients will be treated in a sling for the acute phase of two weeks with progressive physiotherapy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Malunion and/or non-union in this cohort
Radiographic evaluation
Measured: 3 months
Secondary outcomes (1)
Times to union (clinical and radiographic) following fracture
Radiologic evaluation
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2018
- Study start28 Mar 2012
- Primary completion31 Oct 2015
- Study completion31 Oct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Malunion of Fracture of ClavicleStudies of the same condition, open and under way.
- More trials run by McGill University Health Centre/Research Institute of the McGill University Health CentreThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Edward Harvey, McGill University Health Centre/Research Institute of the McGill University Health Centre
- Investigators
- Edward J. Harvey, MDCM, Principal investigator, McGill University Health Centre/Research Institute of the McGill University Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03415958
- Sponsor's protocol ID
- 10-358-PED
- Status last verified
- Jan 2018
- First submitted
- 3 Apr 2014
- Last updated
- 30 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to make IPD available to other researchers.
Publications
Vander Have KL, Perdue AM, Caird MS, Farley FA. Operative versus nonoperative treatment of midshaft clavicle fractures in adolescents. J Pediatr Orthop. 2010 Jun;30(4):307-12. doi: 10.1097/BPO.0b013e3181db3227.
PubMed 20502227Taylor DC, Krasinski KL. Adolescent shoulder injuries: consensus and controversies. J Bone Joint Surg Am. 2009 Feb;91(2):462-73. No abstract available.
PubMed 19181993Kocher MS, Waters PM, Micheli LJ. Upper extremity injuries in the paediatric athlete. Sports Med. 2000 Aug;30(2):117-35. doi: 10.2165/00007256-200030020-00005.
PubMed 10966151Hill JM, McGuire MH, Crosby LA. Closed treatment of displaced middle-third fractures of the clavicle gives poor results. J Bone Joint Surg Br. 1997 Jul;79(4):537-9. doi: 10.1302/0301-620x.79b4.7529.
PubMed 9250733McKee MD, Wild LM, Schemitsch EH. Midshaft malunions of the clavicle. J Bone Joint Surg Am. 2003 May;85(5):790-7. doi: 10.2106/00004623-200305000-00003.
PubMed 12728026McKee MD, Pedersen EM, Jones C, Stephen DJ, Kreder HJ, Schemitsch EH, Wild LM, Potter J. Deficits following nonoperative treatment of displaced midshaft clavicular fractures. J Bone Joint Surg Am. 2006 Jan;88(1):35-40. doi: 10.2106/JBJS.D.02795.
PubMed 16391247Ledger M, Leeks N, Ackland T, Wang A. Short malunions of the clavicle: an anatomic and functional study. J Shoulder Elbow Surg. 2005 Jul-Aug;14(4):349-54. doi: 10.1016/j.jse.2004.09.011.
PubMed 16015232McGraw MA, Mehlman CT, Lindsell CJ, Kirby CL. Postnatal growth of the clavicle: birth to 18 years of age. J Pediatr Orthop. 2009 Dec;29(8):937-43. doi: 10.1097/BPO.0b013e3181c11992.
PubMed 19934713Mehlman CT, Yihua G, Bochang C, Zhigang W. Operative treatment of completely displaced clavicle shaft fractures in children. J Pediatr Orthop. 2009 Dec;29(8):851-5. doi: 10.1097/BPO.0b013e3181c29c9c.
PubMed 19934697Zlowodzki M, Zelle BA, Cole PA, Jeray K, McKee MD; Evidence-Based Orthopaedic Trauma Working Group. Treatment of acute midshaft clavicle fractures: systematic review of 2144 fractures: on behalf of the Evidence-Based Orthopaedic Trauma Working Group. J Orthop Trauma. 2005 Aug;19(7):504-7. doi: 10.1097/01.bot.0000172287.44278.ef.
PubMed 16056089Canadian Orthopaedic Trauma Society. Nonoperative treatment compared with plate fixation of displaced midshaft clavicular fractures. A multicenter, randomized clinical trial. J Bone Joint Surg Am. 2007 Jan;89(1):1-10. doi: 10.2106/JBJS.F.00020.
PubMed 17200303
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Cohort of Displaced Adolescent Midshaft Clavicle Fractures: Are Times to Return to Activities and Functional Outcomes Reasonable for This Population?
- ClinicalTrials.gov ID
- NCT03415958
- Acronym / sponsor ID
- 10-358-PED
- Keywords
- prospective, adolescent, displaced, clavicle, fracture, mid-shaft
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health CentreUniversity, hospital or other
- Study start
- 28 Mar 2012 (actual)
- Primary completion
- 31 Oct 2015 (actual)
- Study completion
- 31 Oct 2016 (actual)
- First posted
- 30 Jan 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.
Outcomes for displaced midshaft clavicle fractures in adolescents are not defined. The current method of treatment for these fractures is non-operative management. There is recent Level 1 evidence in the adult literature to suggest that outcomes are superior when these fractures are managed surgically with open reduction and internal fixation.
Detailed description
The study is a prospective observational cohort design of the natural history of adolescent clavicle fractures treated at the McGill University Health Centre. Surgeon choice will dictate treatment. There is no difference from the current normal therapy choice of each individual surgeon. Patients will be offered either operative or conservative management.
Operative Treatment: Patients with displaced midshaft clavicle fractures will be offered operative treatment which involves open reduction and internal fixation with a plate. This is the standard treatment for completely displaced fractures in the adult population at our Institution based on Level 1 evidence.
Conservative care: Patients will be treated in a sling for the acute phase of two weeks with progressive physiotherapy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Open reduction internal fixation | – | –Patients with displaced midshaft clavicle fractures will be offered operative treatment which involves open reduction and internal fixation. |
| Conservative care | – | –Patients will be treated in a sling for the acute phase of two weeks with progressive physiotherapy. |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Adolescents (ages 12 to 18) who have a displaced clavicle fracture
Key inclusion criteria (3 listed)
- Age 12-18 years old
- The only fracture present in that upper extremity
- Individual and/or parents able to comply with follow-up
Key exclusion criteria (4 listed)
- Head injury
- Prior injury, degenerative condition or congenital condition of the upper extremities
- Systemic disease that may impair healing
- Incapable of ensuring 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.
Primary outcome
Malunion and/or non-union in this cohort
Time frame: 3 months
Radiographic evaluation
1 secondary outcome
Times to union (clinical and radiographic) following fracture
Time frame: 3 months
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 30 Jan 2018.
- Background: PubMed 20502227Vander Have KL, Perdue AM, Caird MS, Farley FA. Operative versus nonoperative treatment of midshaft clavicle fractures in adolescents. J Pediatr Orthop. 2010 Jun;30(4):307-12. doi: 10.1097/BPO.0b013e3181db3227.
- Background: PubMed 19181993Taylor DC, Krasinski KL. Adolescent shoulder injuries: consensus and controversies. J Bone Joint Surg Am. 2009 Feb;91(2):462-73. No abstract available.
- Background: PubMed 10966151Kocher MS, Waters PM, Micheli LJ. Upper extremity injuries in the paediatric athlete. Sports Med. 2000 Aug;30(2):117-35. doi: 10.2165/00007256-200030020-00005.
- Background: PubMed 9250733Hill JM, McGuire MH, Crosby LA. Closed treatment of displaced middle-third fractures of the clavicle gives poor results. J Bone Joint Surg Br. 1997 Jul;79(4):537-9. doi: 10.1302/0301-620x.79b4.7529.
- Background: PubMed 12728026McKee MD, Wild LM, Schemitsch EH. Midshaft malunions of the clavicle. J Bone Joint Surg Am. 2003 May;85(5):790-7. doi: 10.2106/00004623-200305000-00003.
- Background: PubMed 16391247McKee MD, Pedersen EM, Jones C, Stephen DJ, Kreder HJ, Schemitsch EH, Wild LM, Potter J. Deficits following nonoperative treatment of displaced midshaft clavicular fractures. J Bone Joint Surg Am. 2006 Jan;88(1):35-40. doi: 10.2106/JBJS.D.02795.
- Background: PubMed 16015232Ledger M, Leeks N, Ackland T, Wang A. Short malunions of the clavicle: an anatomic and functional study. J Shoulder Elbow Surg. 2005 Jul-Aug;14(4):349-54. doi: 10.1016/j.jse.2004.09.011.
- Background: PubMed 19934713McGraw MA, Mehlman CT, Lindsell CJ, Kirby CL. Postnatal growth of the clavicle: birth to 18 years of age. J Pediatr Orthop. 2009 Dec;29(8):937-43. doi: 10.1097/BPO.0b013e3181c11992.
- Background: PubMed 19934697Mehlman CT, Yihua G, Bochang C, Zhigang W. Operative treatment of completely displaced clavicle shaft fractures in children. J Pediatr Orthop. 2009 Dec;29(8):851-5. doi: 10.1097/BPO.0b013e3181c29c9c.
- Background: PubMed 16056089Zlowodzki M, Zelle BA, Cole PA, Jeray K, McKee MD; Evidence-Based Orthopaedic Trauma Working Group. Treatment of acute midshaft clavicle fractures: systematic review of 2144 fractures: on behalf of the Evidence-Based Orthopaedic Trauma Working Group. J Orthop Trauma. 2005 Aug;19(7):504-7. doi: 10.1097/01.bot.0000172287.44278.ef.
- Background: PubMed 17200303Canadian Orthopaedic Trauma Society. Nonoperative treatment compared with plate fixation of displaced midshaft clavicular fractures. A multicenter, randomized clinical trial. J Bone Joint Surg Am. 2007 Jan;89(1):1-10. doi: 10.2106/JBJS.F.00020.
- Individual participant dataSharing planned: No. There is no plan to make IPD available to other researchers.
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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.
Edward J. Harvey, MDCM principal investigator
McGill University Health Centre/Research Institute of the McGill University Health Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Malunion of Fracture of Clavicle and Delayed Union of Fracture of Clavicle, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
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: finished, as of the sponsor's last update on 30 Jan 2018. 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 Canada. 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?
Malunion and/or non-union in this cohort (time frame: 3 months). 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 NCT03415958, which also lists 11 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 30 Jan 2018.