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Completed

NCT Number: NCT00429585

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

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.

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Key information

Conditions

Tibial Fractures Fractures, Bone Leg Injuries Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Victoria Hospital, London, Ontario, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 anteroposterior (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.

Treatment and study plan

reamed, interlocking intramedullary nail

Device

Standard of care device for tibia fracture repair; Randomized Treatment - Nail

locking periarticular plate

Device

Standard of care device for tibia fracture repair; Randomized Treatment - Plate

Primary outcomes

  1. Participants' Quality of Life at 3 Months

    Time frame: 3 months

    The European Quality of Life Five Dimension (EQ-5D) Survey will be used to measure the participants' quality of life. The EQ-5D measures the subjects' overall state, including 5 domains: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: 1= no problems, 2= slight problems, 3=moderate problems, 4=severe problems and 5=extreme problems. The score is determined by a scale and grading systems that can range from 0.01 to 1.00. The lower the score the less quality of life problems.

  2. Participants' Quality of Life at 6 Months

    Time frame: 6 months

    The European Quality of Life Five Dimension (EQ-5D) Survey will be used to measure the participants' quality of life. The EQ-5D measures the subjects' overall state, including 5 domains: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: 1= no problems, 2= slight problems, 3=moderate problems, 4=severe problems and 5=extreme problems. The score is determined by a scale and grading systems that can range from 0.01 to 1.00. The lower the score the less quality of life problems.

  3. Participants' Quality of Life at 12 Months

    Time frame: 12 months

    The European Quality of Life Five Dimension (EQ-5D) Survey will be used to measure the participants' quality of life. The EQ-5D measures the subjects' overall state, including 5 domains: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: 1= no problems, 2= slight problems, 3=moderate problems, 4=severe problems and 5=extreme problems. The score is determined by a scale and grading systems that can range from 0.01 to 1.00. The higher the score the less quality of life problems.

  4. Injury Related Limitations and Concerns at 3 Months

    Time frame: 3 months

    Participant limitations and bother from the injury will be assessed using the Short Musculoskeletal Function Assessment (SMFA).This survey asks the subject 46 questions, they are broken up into 2 parts. Part 1 relates to the difficulty/limitations the subject has related to their injury. Part 2 is how much the subject is bothered by this injury. Subjects provide score on a scale of 1 (no difficulty/bother) to 5 (highly difficult/bothered). The scoring range is between 0-100. The lower the score the less injury related limitations and bother.

  5. Injury Related Limitations and Concerns at 6 Months

    Time frame: 6 months

    Participant limitations and bother from the injury will be assessed using the Short Musculoskeletal Function Assessment (SMFA).This survey asks the subject 46 questions, they are broken up into 2 parts. Part 1 relates to the difficulty/limitations the subject has related to their injury. Part 2 is how much the subject is bothered by this injury. Subjects provide score on a scale of 1 (no difficulty/bother) to 5 (highly difficult/bothered). The scoring range is between 0-100. The lower the score the less injury related limitations and bother.

  6. Injury Related Limitations and Concerns at 12 Months

    Time frame: 12 month follow-up

    Participant limitations and bother from the injury will be assessed using the Short Musculoskeletal Function Assessment (SMFA).This survey asks the subject 46 questions, they are broken up into 2 parts. Part 1 relates to the difficulty/limitations the subject has related to their injury. Part 2 is how much the subject is bothered by this injury. Subjects provide score on a scale of 1 (no difficulty/bother) to 5 (highly difficult/bothered). The scoring range is between 0-100. The lower the score the less difficulty and bother.

Secondary outcomes

  1. Number of Participants With Fracture Nonunions

    Time frame: 12 months

    A nonunion is when a broken bone fails to heal. This is determined by a review of the participants' medical records and x-rays.

  2. Number of Participants With Superficial Infections

    Time frame: 6 months

    A superficial infection is an infection that occurs at the wound only. Participants are monitored during clinical exams throughout the 12 month follow up appointments and medical records are reviewed.

  3. Number of Participants With Deep Infections

    Time frame: 6 months

    A deep infection is an infection occurring at the site of the nail or plate. Participants are monitored during clinical exams throughout the 12 month follow up appointments and medical records are reviewed.

  4. Number of Participants With Compartment Syndrome

    Time frame: 6 months

    Compartment syndrome is a painful condition that occurs when pressure within the muscles builds to dangerous levels. Participants are monitored during clinical exams throughout the 12 month follow up appointments and medical records are reviewed.

  5. Number of Participants With Malunion (>5 Degrees Varus/Valgus)

    Time frame: 12 months

    Malunion is when a broken bone heals in an abnormal position. In this case, more than a 5 degree angle varus (curving into) or valgus (curving away). This is determined by a review of the participants' medical records and x-rays.

Sponsors and collaborators

Lead sponsor

Boston Medical Center

Other

Collaborators

  • Orthopaedic Trauma Association

Registry information

Official study title

Intramedullary Nail Versus Plate Fixation Re-Evaluation Study in Proximal Tibial Fractures: A Multicenter Randomized Trial Comparing IM Nails and Plate Fixation (IMPRESS)

Important dates

Study start
2007
Primary completion
2020
Study completion
2020
First posted
Feb 1, 2007
Registry last updated
Nov 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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