Radius FractureNCT00955734
Early Motion After Volar Fixation for Distal Radius Fractures
A study testing Early motion and Immobilization in people with Radius Fracture, run by Washington University School of Medicine at 1 site in United States.
Trial summary
Many surgeons pursue volar plating of the distal radius to allow earlier post-operative wrist motion. Early motion is generally prescribed in the belief that it will result in greater final motion without compromising fixation. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Radius Fracture
- What is being tested?
- Early motion and Immobilization
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2009to Jun 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults over 18 years of age having volar internal fixation for distal radius fractures.
Who cannot join
- Patients will be excluded if immobilization is required for distal radioulnar joint instability (whether operatively pinned or simply immobilized in supination) or an associated carpal injury.
- Patients with concurrent fracture of the ulna proximal to the base of the ulnar styloid will be excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: Early Motion After Volar Fixation for Distal Radius Fractures: A Prospective Trial
Many surgeons pursue volar plating of the distal radius to allow earlier post-operative wrist motion. Early motion is generally prescribed in the belief that it will result in greater final motion without compromising fixation. However, studies have failed to demonstrate clinically significant improvement in final wrist motion (> 1 year follow up) compared to treatments requiring longer immobilization such as external fixation or bridge plating.
Read the detailed description
Many surgeons pursue volar plating of the distal radius to allow earlier post-operative wrist motion. Early motion is generally prescribed in the belief that it will result in greater final motion without compromising fixation. However, studies have failed to demonstrate clinically significant improvement in final wrist motion (>1 year follow up) compared to treatments requiring longer immobilization such as external fixation or bridge plating (McQueen 1996, Handoll 2003, Atroshi 2006, Krishnan 2003, Sommerkamp 1994, Grewal 2005).
Only one study to date has attempted to define the early effects of wrist mobilization following volar plate fixation of the distal radius (Lozano-Calderon 2008). That study prospectively enrolled 60 patients and randomized them to begin wrist motion at 2 weeks (range 7 days - 13 days) or 6 weeks (range 42 to 49 days) postoperatively. This study found no significant difference in subjective or objective outcome measures at 3 or 6 months follow up. However, the investigation had several weaknesses. First, there was no attempt to confirm adherence to the immobilization protocols. Those in the late motion group were not casted but remained in orthoplast splints which could be easily removed. Secondly, this investigation collected data only at 3 and 6 months which prohibited them from commenting on the rate of improvement during the early weeks after mobilization. The authors acknowledged these limitations and further noted that no evaluation of patient cost was performed. Finally, radiographic evaluations in this study did not include analysis of change in alignment from immediate postoperative films.
Thus, the literature to date suggests that early mobilization of the volarly plated distal radius is safe but does not improve final wrist motion. The benefits of mobilization in the early postoperative period though have not been clearly defined. This project proposes to fill this void in the literature and determine if early mobilization is an effective measure to hasten recovery of motion and function.
- Conditions
- Radius Fracture
- Being tested
- Early motion, Immobilization
- Keywords
- wrist, fracture, motion, surgery
- Medical subject headings
- Radius Fractures, Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early motionOther
One set of patients will begin wrist motion at 1 week after surgery.
ImmobilizationOther
This set of patients will be casted for 6 weeks after surgery.
| Study group | Role | What they receive |
|---|---|---|
| Early motion | Experimental | This group of patients will begin wrist motion 1 week after surgery. Receives: Other: Early motion |
| Immobilization | Active comparator | This group will be casted for 6 weeks after surgery Receives: Other: Immobilization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wrist Motion
Measured: 2 weeks - 1 year
Secondary outcomes (3)
Patient Function
Measured: 2 weeks - 1 year
Patient Pain
Measured: 2 weeks - 1 year
Fracture reduction
Measured: 2 week - 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2009 (estimated)
- Study startJun 2009
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radius FractureStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ryan Calfee, MD, Washington University School of Medicine
- Investigators
- Ryan Calfee, MD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00955734
- Sponsor's protocol ID
- 09-0566
- Status last verified
- Jun 2015
- First submitted
- 7 Aug 2009
- Last updated
- 29 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Motion After Volar Fixation for Distal Radius Fractures: A Prospective Trial
- ClinicalTrials.gov ID
- NCT00955734
- Acronym / sponsor ID
- 09-0566
- Conditions
- Radius Fracture
- Keywords
- wrist, fracture, motion, surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 10 Aug 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Many surgeons pursue volar plating of the distal radius to allow earlier post-operative wrist motion. Early motion is generally prescribed in the belief that it will result in greater final motion without compromising fixation. However, studies have failed to demonstrate clinically significant improvement in final wrist motion (> 1 year follow up) compared to treatments requiring longer immobilization such as external fixation or bridge plating.
Detailed description
Many surgeons pursue volar plating of the distal radius to allow earlier post-operative wrist motion. Early motion is generally prescribed in the belief that it will result in greater final motion without compromising fixation. However, studies have failed to demonstrate clinically significant improvement in final wrist motion (>1 year follow up) compared to treatments requiring longer immobilization such as external fixation or bridge plating (McQueen 1996, Handoll 2003, Atroshi 2006, Krishnan 2003, Sommerkamp 1994, Grewal 2005).
Only one study to date has attempted to define the early effects of wrist mobilization following volar plate fixation of the distal radius (Lozano-Calderon 2008). That study prospectively enrolled 60 patients and randomized them to begin wrist motion at 2 weeks (range 7 days - 13 days) or 6 weeks (range 42 to 49 days) postoperatively. This study found no significant difference in subjective or objective outcome measures at 3 or 6 months follow up. However, the investigation had several weaknesses. First, there was no attempt to confirm adherence to the immobilization protocols. Those in the late motion group were not casted but remained in orthoplast splints which could be easily removed. Secondly, this investigation collected data only at 3 and 6 months which prohibited them from commenting on the rate of improvement during the early weeks after mobilization. The authors acknowledged these limitations and further noted that no evaluation of patient cost was performed. Finally, radiographic evaluations in this study did not include analysis of change in alignment from immediate postoperative films.
Thus, the literature to date suggests that early mobilization of the volarly plated distal radius is safe but does not improve final wrist motion. The benefits of mobilization in the early postoperative period though have not been clearly defined. This project proposes to fill this void in the literature and determine if early mobilization is an effective measure to hasten recovery of motion and function.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early motion | Experimental | Other: Early motionThis group of patients will begin wrist motion 1 week after surgery. |
| Immobilization | Active comparator | Other: ImmobilizationThis group will be casted for 6 weeks after surgery |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults over 18 years of age having volar internal fixation for distal radius fractures.
Key exclusion criteria (2 listed)
- Patients will be excluded if immobilization is required for distal radioulnar joint instability (whether operatively pinned or simply immobilized in supination) or an associated carpal injury.
- Patients with concurrent fracture of the ulna proximal to the base of the ulnar styloid will be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Early motionOne set of patients will begin wrist motion at 1 week after surgery. | Other | Early motion |
| ImmobilizationThis set of patients will be casted for 6 weeks after surgery. | Other | Immobilization |
Primary outcome
Wrist Motion
Time frame: 2 weeks - 1 year
3 secondary outcomes
Patient Function
Time frame: 2 weeks - 1 year
Patient Pain
Time frame: 2 weeks - 1 year
Fracture reduction
Time frame: 2 week - 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ryan Calfee, MD principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early motion and Immobilization in people with Radius Fracture, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wrist Motion (time frame: 2 weeks - 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2015.