NCT01553630

Brief Summary

Comminuted metaphyseal fractures (OTA classification A2/3 and C2/3) of the distal femur and distal tibia are difficult to treat and typically have more complications than other metaphyseal fractures. Delayed union, nonunion and need for secondary bone graft procedures are frequent outcomes. These A2/3 and C2/3 fractures of the distal femur and distal tibia treated with locked plates often have a critical sized fracture gap (poorly organized cortical pieces many of which are stripped of soft tissue). Optimal management strategies that minimize both fracture healing time and complication rates remain controversial. Primary bone grafts or early secondary bone grafts have been recommended for these comminuted open fractures, but have not been studied as the primary end point in a randomized trial. There is a need to study primary bone grafting during open reduction and internal fixation (plating) of these difficult fractures, to determine if shorter healing time, and thus less need for reoperation, can be achieved. Hypothesis Acute autogenous bone grafting at the time of fixation will hasten clinical and radiographic union with a lower need for secondary procedures

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
6

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
terminated

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, 2010

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

March 8, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 14, 2012

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
Last Updated

November 11, 2014

Status Verified

November 1, 2014

Enrollment Period

4.3 years

First QC Date

March 8, 2012

Last Update Submit

November 10, 2014

Conditions

Femoral FracturesTibial Fractures

Keywords

Fracturesdistal femur fracturesdistal tibial fracures

Outcome Measures

Primary Outcomes (1)

  • Time to union

    This will be evaluated with the reading of xrays

    3 months, 6 months and 1 year

Secondary Outcomes (1)

  • Reoperation rate

    3 months, 6 months, 1 year

Study Arms (2)

RIA bone graft

ACTIVE COMPARATOR

Surgery: open reduction and internal fixation (ORIF) of high energy metaphyseal fractures with Reamed Irrigator Aspirator (RIA) bone graft at the time of fixation.

Procedure: RIA bone graft

Surgery without bone graft

ACTIVE COMPARATOR

Surgery:open reduction and internal fixation (ORIF) of high energy metaphyseal fractures without Reamed Irrigator Aspirator (RIA) bone graft at the time of fixation.

Procedure: Surgery without bone graft

Interventions

RIA bone graftPROCEDURE

Acute autogenous bone grafting with RIA graft at the time of surgical fixation.

RIA bone graft
Surgery without bone graftPROCEDURE

Plating of fracture without bone graft

Surgery without bone graft

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • High energy metaphyseal fracture (distal femur or tibia) indicated for plate fixation (open or closed)
  • Adult, acute fractures only

You may not qualify if:

  • Unable to ream fractured bone
  • Subject is unable, unwilling or unlikely to follow up
  • Subject is under age 18 years
  • Prisoners

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Tampa General Hospital

Tampa, Florida, 33606, United States

Location

St Jospehs Hospital

Tampa, Florida, 33607, United States

Location

Related Publications (1)

  • Claireaux HA, Searle HKC, Parsons NR, Griffin XL. Interventions for treating fractures of the distal femur in adults. Cochrane Database Syst Rev. 2022 Oct 5;10(10):CD010606. doi: 10.1002/14651858.CD010606.pub3.

    PMID: 36197809DERIVED

MeSH Terms

Conditions

Femoral FracturesTibial FracturesFractures, BoneFemoral Fractures, Distal

Interventions

Surgical Procedures, OperativeBone Transplantation

Condition Hierarchy (Ancestors)

Wounds and InjuriesLeg Injuries

Intervention Hierarchy (Ancestors)

Tissue TransplantationCell- and Tissue-Based TherapyBiological TherapyTherapeuticsOrthopedic ProceduresTransplantation

Study Design

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

Study Record Dates

First Submitted

March 8, 2012

First Posted

March 14, 2012

Study Start

May 1, 2010

Primary Completion

August 1, 2014

Study Completion

August 1, 2014

Last Updated

November 11, 2014

Record last verified: 2014-11

Locations

US(2)