A Multicenter Randomized Trial Comparing IM Nails and Plate Fixation in Proximal Tibial Fractures

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Boston Medical Center
Sponsor:
Information provided by (Responsible Party):
Paul Tornetta, III, M.D., Boston Medical Center
ClinicalTrials.gov Identifier:
NCT00429585
First received: January 30, 2007
Last updated: July 15, 2014
Last verified: July 2014
  Purpose

This study looks at two types of surgical treatments and hopes to answer the question: which is the best way to surgically treat a proximal tibia fracture? Both procedures being studied are standard of care (used routinely) and use FDA approved devices. All medical and surgical treatment will be the same for participants as non-participants.


Condition Intervention
Tibial Fractures
Device: reamed, interlocking intramedullary nail
Device: locking periarticular plate

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Intramedullary Nail Versus Plate Fixation Re-Evaluation Study in Proximal Tibial Fractures: A Multicenter Randomized Trial Comparing IM Nails and Plate Fixation (IMPRESS)

Resource links provided by NLM:


Further study details as provided by Boston Medical Center:

Primary Outcome Measures:
  • SF-12v2 [ Time Frame: pre-Op, 3, 6, 12, & 24 month follow-up ] [ Designated as safety issue: No ]
  • EQ-5D [ Time Frame: pre-Op, 3, 6, 12, & 24 month follow-up ] [ Designated as safety issue: No ]
  • SMFA [ Time Frame: pre-Op, 3, 6, 12, & 24 month follow-up ] [ Designated as safety issue: No ]
  • Knee Society Score [ Time Frame: 3, 6, 12, & 24 month follow-up ] [ Designated as safety issue: No ]
  • Clinical Assessment [ Time Frame: 2, 3, 6, 12, & 24 month follow-up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Re-operation (secondary procedures) [ Time Frame: Up to 24 months post-op ] [ Designated as safety issue: Yes ]
  • nonunion [ Time Frame: Until radiographically healed ] [ Designated as safety issue: Yes ]
  • superficial infection rates (wound only) [ Time Frame: Up to 24 months post op ] [ Designated as safety issue: Yes ]
  • deep infection (bone implant interface) [ Time Frame: Up to 24 months post op ] [ Designated as safety issue: Yes ]
  • compartment syndrome [ Time Frame: Up to 24 months post op ] [ Designated as safety issue: Yes ]
  • malunion (>5 degrees varus/valgus) [ Time Frame: Up until radiographically healed ] [ Designated as safety issue: Yes ]
  • >5 degrees anterior or posterior angulation [ Time Frame: Up until radiographically healed ] [ Designated as safety issue: Yes ]
  • >10 malrotation degrees, and >1cm shortening) [ Time Frame: Up until radiographically healed ] [ Designated as safety issue: Yes ]
  • knee range of motion [ Time Frame: Up to 24 months post op ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 160
Study Start Date: February 2007
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Randomized
Randomized Treatment
Device: reamed, interlocking intramedullary nail
Standard of care device for tibia fracture repair
Device: locking periarticular plate
Standard of care device for tibia fracture repair

Detailed Description:

The study is a multicenter randomized controlled trial in which individuals sustaining a fracture of the proximal metaphysis of the tibia will be operatively managed by one of two strategies. The first strategy involves fixation of the fracture with a reamed, interlocking intramedullary nail (Nail Group). The second treatment strategy involves open reduction and internal fixation of the fracture with a locking periarticular plate (Plate Group). The null hypothesis of the study is that there will be no difference in the two groups with respect to the primary and secondary outcome measures. To the degree possible, patients in the two groups will receive post-operative care according to the same standards and protocols.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Skeletally mature,
  • Extra-articular fracture of the proximal tibia extending into the metaphyseal with or without intra-articular extension not requiring open reduction with complete AP and lateral radiographs,
  • Major fracture line not closer than 4cm from the proximal tibial articular surface
  • Fracture requiring operative treatment amenable to either IM nail or plate
  • Surgeon agreed to randomize patient
  • Informed consent obtained
  • Patient is English speaking

Exclusion Criteria:

  • Tibial shaft fractures not amenable to intramedullary nailing (i.e.fracture is less than 4 cm from joint surface),
  • Fracture of the proximal tibia with intraarticular extension requiring open reduction,
  • Known metabolic bone disease
  • Separate displaced tibial tubercle fragment,
  • Soft tissue injuries compromising treatment method with nail,plate or both.
  • Fractures with vascular injury (Gustillo Type IIIC injury) requiring repair,
  • Compartment syndrome of the leg diagnosed preoperatively,
  • Pathological fractures,
  • Retained hardware or existing deformity in the affected limb that would complicate IM nailing,plating or both,
  • Symptomatic knee arthritis.
  • Surgical delay greater than 3 weeks for closed fractures or 24 hours for open fractures,
  • Immunocompromised,
  • Unable to comply with postoperative rehabilitation protocols or instructions (i.e. head injured or mentally impaired),
  • Current or impending incarceration,
  • Unlikely to follow-up in surgeon's estimation.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00429585

Contacts
Contact: Paul Tornetta 617-414-6295 heather.desjardin@bmc.org
Contact: paul tornetta ptornetta@gmail.com

  Show 30 Study Locations
Sponsors and Collaborators
Boston Medical Center
Investigators
Principal Investigator: Paul Tornetta, M.D. Boston University
  More Information

No publications provided

Responsible Party: Paul Tornetta, III, M.D., Paul Tornetta, III, MD,, Boston Medical Center
ClinicalTrials.gov Identifier: NCT00429585     History of Changes
Other Study ID Numbers: H-25923
Study First Received: January 30, 2007
Last Updated: July 15, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Boston Medical Center:
tibia fracture
proximal tibia

Additional relevant MeSH terms:
Fractures, Bone
Tibial Fractures
Wounds and Injuries
Leg Injuries

ClinicalTrials.gov processed this record on August 28, 2014