Clinical trial NCT01293227: WRx Distal Radius Wrist Fracture Study
Official title: The Effect of Intramedullary Locked Nail Versus Volar Locked Plating in the Treatment of Extra-articular and Minimally Displaced Intra-articular Distal Radius Fractures: A Prospective Randomized Trial.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Wrist Fracture
Keywords: Wrist Fracture
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2011-02-10
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This research project is a multi-year proposal, with the goals of answering and evaluating the following:

1. Does an intramedullary locking device applied in an extra-articular distal radius fracture improve post operative pain, diminish hospitalization, improve early return to activity and function compared to a volar locked plate?
2. Does an intramedullary locking device applied in an extra-articular distal radius fracture improve patient related outcome measures compared to a volar locked plate?


Eligibility criteria: Inclusion Criteria

The following criteria must be met to be enrolled:

1. Have a closed extra-articular distal radius fracture or a minimally displaced intra-articular component
2. Have a fracture classified as an AO Type A or C1 with or without an ulnar styloid fracture
3. Be a male or non-pregnant female at least 18 years of age.
4. Understand the requirements of the study and able to provide a written informed consent and comply with the study protocol
5. Have the ability to understand and provide written authorization for use and disclosure of personal health information
6. Have a fracture that can be closed reduced to acceptable radiographic parameters (minimum of neutral volar tilt, greater than or equal to 15 degrees of radial inclination and at least 10 mm of radial height as compared to the opposite side)

Exclusion Criteria

Subjects are excluded if:

1. Have any of the following conditions

   1. Concomitant contralateral or ipsilateral upper extremity fractures
   2. Ipsilateral ulna (excluding styloid) fracture
   3. Open, multifragmentary fracture
   4. Unstable distal radioulnar joint after fracture fixation
   5. Artery or Nerve injury secondary to fracture
2. Previous ipsilateral distal radius fracture in the 2 years prior to enrollment with deformity
3. Currently on chemotherapy or radiation therapy
4. History of a metabolic disorder affecting the skeletal system other than osteoarthritis or osteoporosis
5. History of uncontrolled diabetes
6. History of active rheumatologic disease with deformity
7. History of chronic pain issues, psychiatric disorder which precludes reliable follow-up
8. Unable to provide consent for the study
9. Unable to make the follow-up appointments required of the study

Primary outcomes:
measure: Change in Pain (to no pain)
timeFrame: Baseline to week 52 after surgery
Secondary outcomes:
measure: Change in range of motion measurements
timeFrame: Basline to week 52 after surgery
measure: Grip and Pinch
timeFrame: Baseline to week 52 after surgery
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Alexander Shin, MD
role: PRINCIPAL_INVESTIGATOR
References: