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

Tibial Fractures Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00429585
• Other study ID #: H-25923
• Status: Completed
• Phase: N/A
• Start date: February 2007
• Est. completion date: December 16, 2020

Study information

• Verified date: October 2021
• Source: Boston Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: December 16, 2020
• Est. primary completion date: November 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Fractures, Bone
• Tibial Fractures

Intervention

Device:
• reamed, interlocking intramedullary nail
Standard of care device for tibia fracture repair; Randomized Treatment - Nail
• locking periarticular plate
Standard of care device for tibia fracture repair; Randomized Treatment - Plate

Locations

Country	Name	City	State
Canada	Victoria Hospital	London	Ontario
Canada	St. Michaels Hospital - Toronto	Toronto	Ontario
United States	University of Michigan Hospital	Ann Arbor	Michigan
United States	University of Maryland Medical Center	Baltimore	Maryland
United States	University of Alabama - Burmingham	Birmingham	Alabama
United States	Boston Medical Center	Boston	Massachusetts
United States	Cooper University Hospital	Camden	New Jersey
United States	Ohio State University Medical Center	Columbus	Ohio
United States	University of California at Davis	Davis	California
United States	Duke University Medical Center	Durham	North Carolina
United States	Orthopaedic Specialty Associates - Fort Worth	Fort Worth	Texas
United States	Orthopaedic Associates of Michigan	Grand Rapids	Michigan
United States	Indiana University	Indianapolis	Indiana
United States	IU Health Methodist Hospital	Indianapolis	Indiana
United States	Campbell Foundation	Memphis	Tennessee
United States	Hennepin County Medical Center	Minneapolis	Minnesota
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	New York Hospital for Joint Diseases	New York	New York
United States	University of Oklahoma/ Health Science	Oklahoma City	Oklahoma
United States	University Of Pittsburgh	Pittsburgh	Pennsylvania
United States	Oregon health and science university	Portland	Oregon
United States	St. Mary's Hospital - Mayo Clinic	Rochester	Minnesota
United States	University of Rochester Medical Center	Rochester	New York
United States	Barnes Hospital	Saint Louis	Missouri
United States	St. Louis University Hospital	Saint Louis	Missouri
United States	University of California-San Francisco	San Francisco	California
United States	Harborview Medical Center	Seattle	Washington
United States	Tampa General Hospital	Tampa	Florida
United States	UMass Memorial Medical Center	Worcester	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Boston Medical Center	Orthopaedic Trauma Association

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Participants' Quality of Life at 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.	3 months
Primary	Participants' Quality of Life at 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.	6 months
Primary	Participants' Quality of Life at 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.	12 months
Primary	Injury Related Limitations and Concerns at 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.	3 months
Primary	Injury Related Limitations and Concerns at 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 months
Primary	Injury Related Limitations and Concerns at 12 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 difficulty and bother.	12 month follow-up
Secondary	Number of Participants With Fracture Nonunions	A nonunion is when a broken bone fails to heal. This is determined by a review of the participants' medical records and x-rays.	12 months
Secondary	Number of Participants With Superficial Infections	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.	6 months
Secondary	Number of Participants With Deep Infections	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.	6 months
Secondary	Number of Participants With Compartment Syndrome	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.	6 months
Secondary	Number of Participants With Malunion (>5 Degrees Varus/Valgus)	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.	12 months