Radius Fractures Clinical Trial
Official title:
The Effect of Early vs. Delayed Range of Motion in the Outcome of Patients With Distal Radius Fractures
Verified date | April 2011 |
Source | Mayo Clinic |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
Hypothesis : Early active range of motion protocol after open reduction and internal
fixation of a distal radius fracture with a volar fixed angle locking plate results in
earlier return of functional motion, earlier return to work and improved functional outcomes
compared delayed mobilization.
Specific Aim:
To compare early range of motion versus delayed motion protocol in distal radius fractures
treated with open reduction and internal fixation with a volar fixed angle locking plate
with respect to time to fracture union, range of motion, functional outcome measures, return
to work and complications.
Status | Completed |
Enrollment | 39 |
Est. completion date | February 2010 |
Est. primary completion date | February 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 85 Years |
Eligibility |
Inclusion Criteria: The following criteria must be met to be enrolled: 1. Have a closed unstable distal radius fracture 2. Have a fracture classified as an AO Type A or C fracture, 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 Exclusion Criteria: Participants are excluded if they: 1. Have any of the following conditions 1. Concomitant contralateral or ipsilateral upper extremity fractures 2. Ipsilateral ulna (excluding styloid) fracture 3. Open, multi-fragmentary fracture 4. Artery or Nerve injury secondary to fracture 2. Have had a previous ipsilateral distal radius fracture in the 2 years prior to enrollment 3. Are currently on chemotherapy or radiation therapy 4. A history of a metabolic disorder affecting the skeletal system other than osteoarthritis or osteoporosis 5. A history of uncontrolled diabetes 6. Are unable to provide consent for the study 7. Are unable to make the follow-up appointments required of the study |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Mayo Clinic | Rochester | Minnesota |
Lead Sponsor | Collaborator |
---|---|
Mayo Clinic | DePuy Orthopaedics |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Range of motion measurements | at each study visit | No | |
Secondary | Pinch strength | at each study visit | No | |
Secondary | Grip strength | at each study visit | No | |
Secondary | Pain | at each study visit | No | |
Secondary | Return to work | at each study visit | No | |
Secondary | Scores of DASH & PRWE questionnaires | at each study visit | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT00161629 -
Study Evaluating rhBMP-2/CPM in Closed Distal Radius Fractures
|
Phase 1 | |
Completed |
NCT03531801 -
Referred Pain Areas in Subjects With a Recovered Radius Fracture
|
||
Completed |
NCT03297047 -
Comparing Forearm and Upper Arm Combi Cast for Distal Forearm Fractures in Children
|
N/A | |
Recruiting |
NCT00271726 -
Operative Treatment of Extraarticular Colles' Fractures of the Distal Radius (OTEC)
|
N/A | |
Completed |
NCT03496337 -
Is AMPS a Responsive Tool for Assessing Change in ADL-abilities After Finger or Hand Surgery
|
||
Completed |
NCT00274378 -
Allomatrix Injectable Putty in Distal Radius Fractures
|
Phase 4 | |
Not yet recruiting |
NCT04930718 -
Thumb and Wrist Proprioception Exercises.
|
N/A | |
Completed |
NCT04062110 -
Below-elbow or Above-elbow Cast for Extra-articular Distal Radius Fractures
|
N/A | |
Completed |
NCT02840188 -
Young Goalkeeper's Fracture: Radiographic Findings
|
N/A | |
Completed |
NCT02505633 -
Comparison 1 Plane-1 Injection and 2 Plane-2 Injection Ultrasound-guided Supraclavicular Brachial Plexus Block
|
N/A | |
Completed |
NCT03423043 -
Low Dose CT Distal Radius Fractures
|
||
Completed |
NCT03438864 -
Acute Effects of Interferential Current on Edema, Pain and Muscle Strength in Patients With Distal Radius Fracture
|
N/A | |
Completed |
NCT02670629 -
Management of Distal Radius Fractures in Children Younger Than 11 Years Old.
|
N/A | |
Completed |
NCT00989222 -
Volar Plating or External Fixation of Dorsally Displaced Fractures of the Distal Radius?
|
N/A | |
Active, not recruiting |
NCT06067074 -
Cost-effectiveness, Volar Locking Plate or Non-operative Treatment Distal Radius Fracture
|
N/A | |
Completed |
NCT02348437 -
Repair vs Non-repair of the Pronator Quadratus Muscle in Distal Radius Fractures. RCT.
|
N/A | |
Completed |
NCT02630290 -
Addition of Dexmedetomidine to Ropivacaine-induced Supraclavicular Block (ADRIB Trial)
|
Phase 4 | |
Completed |
NCT01262807 -
Reducing Range of Motion Deficits Post Radial Fracture
|
N/A | |
Completed |
NCT03570905 -
Radiographic and Clinical Comparison of Post-reduction Splinting Constructs in the Treatment of Acute Displaced Distal Radius Fractures
|
N/A | |
Completed |
NCT02533557 -
Comparison 1 Plane-2 Injection and 2 Plane-2 Injection Ultrasound-guided Supraclavicular Brachial Plexus Block
|
N/A |