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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00429585
Recruitment Status : Active, not recruiting
First Posted : February 1, 2007
Last Update Posted : January 14, 2020
Sponsor:
Collaborator:
Orthopaedic Trauma Association
Information provided by (Responsible Party):
Boston Medical Center

Brief Summary:
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 or disease Intervention/treatment Phase
Tibial Fractures Device: reamed, interlocking intramedullary nail Device: locking periarticular plate Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 108 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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)
Actual Study Start Date : February 2007
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Randomized Treatment - Nail
Randomized Treatment - Nail
Device: reamed, interlocking intramedullary nail
Standard of care device for tibia fracture repair; Randomized Treatment - Nail

Randomized Treatment - Plate
Randomized Treatment - Plate
Device: locking periarticular plate
Standard of care device for tibia fracture repair; Randomized Treatment - Plate




Primary Outcome Measures :
  1. SF-12v2 [ Time Frame: pre-Op, 3, 6, 12, & 24 month follow-up ]
  2. EQ-5D [ Time Frame: pre-Op, 3, 6, 12, & 24 month follow-up ]
  3. SMFA [ Time Frame: pre-Op, 3, 6, 12, & 24 month follow-up ]
  4. Knee Society Score [ Time Frame: 3, 6, 12, & 24 month follow-up ]
  5. Clinical Assessment [ Time Frame: 2, 3, 6, 12, & 24 month follow-up ]

Secondary Outcome Measures :
  1. Re-operation (secondary procedures) [ Time Frame: Up to 24 months post-op ]
  2. nonunion [ Time Frame: Until radiographically healed ]
  3. superficial infection rates (wound only) [ Time Frame: Up to 24 months post op ]
  4. deep infection (bone implant interface) [ Time Frame: Up to 24 months post op ]
  5. compartment syndrome [ Time Frame: Up to 24 months post op ]
  6. malunion (>5 degrees varus/valgus) [ Time Frame: Up until radiographically healed ]
  7. >5 degrees anterior or posterior angulation [ Time Frame: Up until radiographically healed ]
  8. >10 malrotation degrees, and >1cm shortening) [ Time Frame: Up until radiographically healed ]
  9. knee range of motion [ Time Frame: Up to 24 months post op ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00429585


Locations
Show Show 29 study locations
Sponsors and Collaborators
Boston Medical Center
Orthopaedic Trauma Association
Investigators
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Principal Investigator: Paul Tornetta, M.D. Boston University

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Responsible Party: Boston Medical Center
ClinicalTrials.gov Identifier: NCT00429585    
Other Study ID Numbers: H-25923
First Posted: February 1, 2007    Key Record Dates
Last Update Posted: January 14, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Boston Medical Center:
tibia fracture
proximal tibia
interlocking intramedullary nail
locking periarticular plate
open reduction
internal fixation
Additional relevant MeSH terms:
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Fractures, Bone
Tibial Fractures
Wounds and Injuries
Leg Injuries