NCT00038129

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2002

Longer than P75 for not_applicable

Geographic Reach
1 country

16 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2002

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

May 29, 2002

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 30, 2002

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2006

Completed
Last Updated

November 1, 2019

Status Verified

October 1, 2019

Enrollment Period

4.5 years

First QC Date

May 29, 2002

Last Update Submit

October 30, 2019

Conditions

Tibial Fracture

Outcome Measures

Primary Outcomes (1)

  • Necessity for additional operation

    Months 6, 9, and 12

Secondary Outcomes (1)

  • Return to work, functional status, and health-related quality of life

    Months 6, 9, and 12

Study Arms (2)

1

EXPERIMENTAL

Participants will receive reaming of the intramedullary canal prior to insertion of an intramedullary nail.

Procedure: Intramedullary nail implant

2

EXPERIMENTAL

Participants will receive insertion of an intramedullary nail without prior reaming of the intramedullary canal.

Procedure: Intramedullary nail implant

Interventions

Intramedullary nail implantPROCEDURE

Insertion of an intramedullary nail during tibial fracture fixation with or without prior reaming of the intramedullary canal.

12

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Fractured tibia requiring fixation using an intramedullary nail

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (16)

San Francisco General Hospital

San Francisco, California, 94110, United States

Location

University of Florida - Jacksonville

Jacksonville, Florida, 32209, United States

Location

Deaconess Hospital

Evansville, Indiana, 47710, United States

Location

University of Louisville

Louisville, Kentucky, 40202, United States

Location

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

Detroit Receiving Hospital

Detroit, Michigan, 48201, United States

Location

Regions Hospital

Saint Paul, Minnesota, 55101, United States

Location

University of Buffalo

Buffalo, New York, 14215, United States

Location

Jamaica Hospital

Jamaica, New York, 11418, United States

Location

Wake Medical Center

Raleigh, North Carolina, 27610, United States

Location

Wake Forest Medical Center

Winston-Salem, North Carolina, 27157, United States

Location

Metrohealth Medical Center

Cleveland, Ohio, 44109, United States

Location

University of Oklahoma

Oklahoma City, Oklahoma, 73190, United States

Location

Oregon Health & Science Univesity

Portland, Oregon, 97201, United States

Location

Vanderbilt University

Nashville, Tennessee, 37232, United States

Location

Memorial Hermann Hospital

Houston, Texas, 77030, United States

Location

Related Publications (7)

  • 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.

    PMID: 37442585DERIVED

  • Swiontkowski 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.

    PMID: 34222771DERIVED

  • Khan 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.

    PMID: 27543531DERIVED

  • Busse 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.

    PMID: 22011635DERIVED

  • SPRINT 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.

    PMID: 21669369DERIVED

  • Busse 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.

    PMID: 19364637DERIVED

  • SPRINT 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.

    PMID: 18573205DERIVED

MeSH Terms

Conditions

Tibial Fractures

Interventions

Fracture Fixation, Intramedullary

Condition Hierarchy (Ancestors)

Fractures, BoneWounds and InjuriesLeg Injuries

Intervention Hierarchy (Ancestors)

Fracture Fixation, InternalFracture FixationOrthopedic ProceduresTherapeuticsSurgical Procedures, Operative

Study Officials

  • Marc F. Swiontkowski, MD

    Department of Orthopaedic Surgery, University of Minnesota

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 29, 2002

First Posted

May 30, 2002

Study Start

May 1, 2002

Primary Completion

November 1, 2006

Study Completion

November 1, 2006

Last Updated

November 1, 2019

Record last verified: 2019-10

Locations

US(16)