Tibial FractureNCT00038129
SPRINT - Randomized Trial of Tibial Fracture Fixation
A study testing Intramedullary nail implant in people with Tibial Fracture, run by University of Minnesota at 16 sites in United States.
Trial summary
The purpose of this study is to determine if there is a difference in the rate of healing of a tibia fracture treated with an intramedullary nail based on whether or not the bone was reamed prior to nail insertion. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Tibial Fracture
- What is being tested?
- Intramedullary nail implant
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,200 participants
- Where
- 16 sitesUnited States
- Study dates
- May 2002to Nov 2006
- 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 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Fractured tibia requiring fixation using an intramedullary nail
Who cannot join
None listed.
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
United States16 sites
Boston Medical Center
Boston, Massachusetts, 02118
University of Buffalo
Buffalo, New York, 14215
Metrohealth Medical Center
Cleveland, Ohio, 44109
Detroit Receiving Hospital
Detroit, Michigan, 48201
Deaconess Hospital
Evansville, Indiana, 47710
Memorial Hermann Hospital
Houston, Texas, 77030
University of Florida - Jacksonville
Jacksonville, Florida, 32209
Jamaica Hospital
Jamaica, New York, 11418
University of Louisville
Louisville, Kentucky, 40202
Vanderbilt University
Nashville, Tennessee, 37232
University of Oklahoma
Oklahoma City, Oklahoma, 73190
Oregon Health & Science Univesity
Portland, Oregon, 97201
Wake Medical Center
Raleigh, North Carolina, 27610
Regions Hospital
Saint Paul, Minnesota, 55101
San Francisco General Hospital
San Francisco, California, 94110
Wake Forest Medical Center
Winston-Salem, North Carolina, 27157
About this study
Official title: Study to Prospectively Evaluate Reamed Intramedullary Nails in Tibial Shaft Fractures (SPRINT)
The purpose of this study is to determine if there is a difference in the rate of healing of a tibia fracture treated with an intramedullary nail based on whether or not the bone was reamed prior to nail insertion.
Read the detailed description
Patients with tibia fractures that are amenable to being treated with both a reamed and an unreamed nail will be randomized via telephone to one of the two groups. These patients then will be followed for a year with clinical, as well as subjective, outcome follow-up questionnaires. Time to healing, as well as repeat interventions and adverse events, will be tracked. The rationale for doing a large sample size multi-center trial is the hope that a clear answer to whether or not one of these two methods is significantly better than the other will become apparent and thus aid surgeons in making a more informed operative treatment choice.
- Conditions
- Tibial Fracture
- Being tested
- Intramedullary nail implant
- Medical subject headings
- Tibial Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intramedullary nail implantProcedure or surgery
Insertion of an intramedullary nail during tibial fracture fixation with or without prior reaming of the intramedullary canal.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Participants will receive reaming of the intramedullary canal prior to insertion of an intramedullary nail. Receives: Procedure: Intramedullary nail implant |
| 2 | Experimental | Participants will receive insertion of an intramedullary nail without prior reaming of the intramedullary canal. Receives: Procedure: Intramedullary nail implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Necessity for additional operation
Measured: Months 6, 9, and 12
Secondary outcomes (1)
Return to work, functional status, and health-related quality of life
Measured: Months 6, 9, and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2002 (estimated)
- Study startMay 2002
- Primary completionNov 2006
- Study completionNov 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Tibial FractureStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe 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
- None (open label)
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Responsible party
- Sponsor
- Investigators
- Marc F. Swiontkowski, MD, Study chair, Department of Orthopaedic Surgery, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00038129
- Sponsor's protocol ID
- 0105M00481
- Other IDs
- R01AR048529, NIAMS-072
- Status last verified
- Oct 2019
- First submitted
- 29 May 2002
- Last updated
- 1 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Schemitsch EH, Kumar A, Heels-Ansdell D, Sprague S, Bhandari M, Guyatt G, Sanders DW, Swiontkowski M, Tornetta P 3rd, Walter S; SPRINT Investigators. Reamed compared with unreamed nailing of tibial shaft fractures: Does the initial method of nail insertion influence outcome in patients requiring reoperations? Can J Surg. 2023 Jul 13;66(4):E384-E389. doi: 10.1503/cjs.012222. Print 2023 Jul-Aug.
PubMed 37442585Swiontkowski M, Teague D, Sprague S, Bzovsky S, Heels-Ansdell D, Bhandari M, Schemitsch EH, Sanders DW, Tornetta P, Walter SD; SPRINT Investigators. Impact of centre volume, surgeon volume, surgeon experience and geographic location on reoperation after intramedullary nailing of tibial shaft fractures. Can J Surg. 2021 Jul 5;64(4):E371-E376. doi: 10.1503/cjs.004020.
PubMed 34222771Khan JS, Devereaux PJ, LeManach Y, Busse JW. Patient coping and expectations about recovery predict the development of chronic post-surgical pain after traumatic tibial fracture repair. Br J Anaesth. 2016 Sep;117(3):365-70. doi: 10.1093/bja/aew225.
PubMed 27543531Busse JW, Bhandari M, Guyatt GH, Heels-Ansdell D, Kulkarni AV, Mandel S, Sanders D, Schemitsch E, Swiontkowski M, Tornetta P 3rd, Wai E, Walter SD; SPRINT Investigators & the Medically Unexplained Syndromes Study Group. Development and validation of an instrument to predict functional recovery in tibial fracture patients: the Somatic Pre-Occupation and Coping (SPOC) questionnaire. J Orthop Trauma. 2012 Jun;26(6):370-8. doi: 10.1097/BOT.0b013e31822421e2.
PubMed 22011635SPRINT Investigators; Briel M, Sprague S, Heels-Ansdell D, Guyatt G, Bhandari M, Blackhouse G, Sanders D, Schemitsch E, Swiontkowski M, Tornetta P 3rd, Walter SD, Goeree R. Economic evaluation of reamed versus unreamed intramedullary nailing in patients with closed and open tibial fractures: results from the study to prospectively evaluate reamed intramedullary nails in patients with tibial fractures (SPRINT). Value Health. 2011 Jun;14(4):450-7. doi: 10.1016/j.jval.2010.10.034. Epub 2011 May 25.
PubMed 21669369Busse JW, Bhandari M, Guyatt GH, Heels-Ansdell D, Mandel S, Sanders D, Schemitsch E, Swiontkowski M, Tornetta P 3rd, Wai E, Walter SD; SPRINT Investigators. Use of both Short Musculoskeletal Function Assessment questionnaire and Short Form-36 among tibial-fracture patients was redundant. J Clin Epidemiol. 2009 Nov;62(11):1210-7. doi: 10.1016/j.jclinepi.2009.01.014. Epub 2009 Apr 11.
PubMed 19364637SPRINT Investigators; Bhandari M, Guyatt G, Tornetta P 3rd, Schemitsch E, Swiontkowski M, Sanders D, Walter SD. Study to prospectively evaluate reamed intramedually nails in patients with tibial fractures (S.P.R.I.N.T.): study rationale and design. BMC Musculoskelet Disord. 2008 Jun 23;9:91. doi: 10.1186/1471-2474-9-91.
PubMed 18573205
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study to Prospectively Evaluate Reamed Intramedullary Nails in Tibial Shaft Fractures (SPRINT)
- ClinicalTrials.gov ID
- NCT00038129
- Acronym / sponsor ID
- 0105M00481
- Conditions
- Tibial Fracture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Study start
- May 2002
- Primary completion
- Nov 2006 (actual)
- Study completion
- Nov 2006 (actual)
- First posted
- 30 May 2002 (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 purpose of this study is to determine if there is a difference in the rate of healing of a tibia fracture treated with an intramedullary nail based on whether or not the bone was reamed prior to nail insertion.
Detailed description
Patients with tibia fractures that are amenable to being treated with both a reamed and an unreamed nail will be randomized via telephone to one of the two groups. These patients then will be followed for a year with clinical, as well as subjective, outcome follow-up questionnaires. Time to healing, as well as repeat interventions and adverse events, will be tracked. The rationale for doing a large sample size multi-center trial is the hope that a clear answer to whether or not one of these two methods is significantly better than the other will become apparent and thus aid surgeons in making a more informed operative treatment choice.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: Intramedullary nail implantParticipants will receive reaming of the intramedullary canal prior to insertion of an intramedullary nail. |
| 2 | Experimental | Procedure: Intramedullary nail implantParticipants will receive insertion of an intramedullary nail without prior reaming of the intramedullary canal. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Fractured tibia requiring fixation using an intramedullary nail
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Intramedullary nail implantInsertion of an intramedullary nail during tibial fracture fixation with or without prior reaming of the intramedullary canal. | Procedure or surgery | 1, 2 |
Primary outcome
Necessity for additional operation
Time frame: Months 6, 9, and 12
1 secondary outcome
Return to work, functional status, and health-related quality of life
Time frame: Months 6, 9, and 12
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 1 Nov 2019.
- Derived from this study: PubMed 37442585Schemitsch EH, Kumar A, Heels-Ansdell D, Sprague S, Bhandari M, Guyatt G, Sanders DW, Swiontkowski M, Tornetta P 3rd, Walter S; SPRINT Investigators. Reamed compared with unreamed nailing of tibial shaft fractures: Does the initial method of nail insertion influence outcome in patients requiring reoperations? Can J Surg. 2023 Jul 13;66(4):E384-E389. doi: 10.1503/cjs.012222. Print 2023 Jul-Aug.
- Derived from this study: PubMed 34222771Swiontkowski M, Teague D, Sprague S, Bzovsky S, Heels-Ansdell D, Bhandari M, Schemitsch EH, Sanders DW, Tornetta P, Walter SD; SPRINT Investigators. Impact of centre volume, surgeon volume, surgeon experience and geographic location on reoperation after intramedullary nailing of tibial shaft fractures. Can J Surg. 2021 Jul 5;64(4):E371-E376. doi: 10.1503/cjs.004020.
- Derived from this study: PubMed 27543531Khan JS, Devereaux PJ, LeManach Y, Busse JW. Patient coping and expectations about recovery predict the development of chronic post-surgical pain after traumatic tibial fracture repair. Br J Anaesth. 2016 Sep;117(3):365-70. doi: 10.1093/bja/aew225.
- Derived from this study: PubMed 22011635Busse JW, Bhandari M, Guyatt GH, Heels-Ansdell D, Kulkarni AV, Mandel S, Sanders D, Schemitsch E, Swiontkowski M, Tornetta P 3rd, Wai E, Walter SD; SPRINT Investigators & the Medically Unexplained Syndromes Study Group. Development and validation of an instrument to predict functional recovery in tibial fracture patients: the Somatic Pre-Occupation and Coping (SPOC) questionnaire. J Orthop Trauma. 2012 Jun;26(6):370-8. doi: 10.1097/BOT.0b013e31822421e2.
- Derived from this study: PubMed 21669369SPRINT Investigators; Briel M, Sprague S, Heels-Ansdell D, Guyatt G, Bhandari M, Blackhouse G, Sanders D, Schemitsch E, Swiontkowski M, Tornetta P 3rd, Walter SD, Goeree R. Economic evaluation of reamed versus unreamed intramedullary nailing in patients with closed and open tibial fractures: results from the study to prospectively evaluate reamed intramedullary nails in patients with tibial fractures (SPRINT). Value Health. 2011 Jun;14(4):450-7. doi: 10.1016/j.jval.2010.10.034. Epub 2011 May 25.
- Derived from this study: PubMed 19364637Busse JW, Bhandari M, Guyatt GH, Heels-Ansdell D, Mandel S, Sanders D, Schemitsch E, Swiontkowski M, Tornetta P 3rd, Wai E, Walter SD; SPRINT Investigators. Use of both Short Musculoskeletal Function Assessment questionnaire and Short Form-36 among tibial-fracture patients was redundant. J Clin Epidemiol. 2009 Nov;62(11):1210-7. doi: 10.1016/j.jclinepi.2009.01.014. Epub 2009 Apr 11.
- Derived from this study: PubMed 18573205SPRINT Investigators; Bhandari M, Guyatt G, Tornetta P 3rd, Schemitsch E, Swiontkowski M, Sanders D, Walter SD. Study to prospectively evaluate reamed intramedually nails in patients with tibial fractures (S.P.R.I.N.T.): study rationale and design. BMC Musculoskelet Disord. 2008 Jun 23;9:91. doi: 10.1186/1471-2474-9-91.
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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.
Marc F. Swiontkowski, MD study chair
Department of Orthopaedic Surgery, University of Minnesota
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intramedullary nail implant in people with Tibial Fracture, run by University of Minnesota at 16 sites in United States.
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 0 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 1 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in United States. 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?
Necessity for additional operation (time frame: Months 6, 9, and 12). 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 NCT00038129, which also lists 7 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 1 Nov 2019.