Wrist FracturesNCT00828685
Early Functional Outcomes After Closed Reduction With Pinning Versus Open Reduction Internal Fixation of Wrist Fractures
A study testing CRPP and ORIF in people with Wrist Fractures, run by Beth Israel Deaconess Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to compare early return to function in patients treated with closed reduction percutaneous pinning and open reduction internal fixation in displaced fractures of the distal radius. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Wrist Fractures
- What is being tested?
- CRPP and ORIF
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years or greater
- Patient functions independently
- Dorsally displaced, extra-articular fracture (Colles' fracture); or simple intra-articular fracture with a single split between the scaphoid and lunate facets.
- Isolated injury (no other injuries).
- One of the following criteria:
- Substantial initial displacement
Show all 21Show fewer
- Greater than 20 degrees dorsal angulation of the articular surface on the lateral view.
- Greater than 100% loss of apposition.
- Greater than 5 millimeters of shortening by ulnar variance on the posteroanterior radiograph.
- Greater than 2 millimeters articular incongruity (step or gap).
- Both dorsal and volar comminution. Inadequate initial manipulative reduction
- Greater than 5 degrees of dorsal angulation of the articular surface on the lateral radiograph.
- Greater than 3 millimeters of radial shortening by ulnar variance on the posteroanterior radiograph.
- Greater than 2 millimeters articular incongruity.
- Bayonett apposition of the volar cortex.
- Less than 15 degrees of ulnarward inclination of the articular surface in the posteroanterior radiograph. Loss of reduction within 3 weeks of injury.
- Any of the following changes in alignment from the initial post- reduction radiographs qualify:
- 5 degrees or greater loss of palmar tilt of the articular surface on the lateral radiograph.
- 2 millimeters or greater loss of radial height by ulnar variance on the posteroanterior radiograph.
- 5 degrees or greater loss of ulnarward inclination of the articular surface of the distal radius on the posteroanteriorradiograph.
- 2 millimeters or greater articular incongruity.
Who cannot join
- More complex articular fractures (i.e. anything more than a simple sagittal split between the scaphoid and lunate facets).
- Volarly displaced fractures.
- Infirm patients.
- Patients that rely on others for basic functional activities.
- Open fractures
- Fractures associated with neurovascular injury.
- Fractures associated with major head, neurological, or visceral injuries that will inhibit the ability to participate in a structured exercise program.
- Associated musculoskeletal injuries to the same arm.
Trial locations and contacts
1 site in 1 country.
United States1 site
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
About this study
Official title: Early Functional Outcomes After Closed Reduction Percutaneous Pinning vs. Open Reduction Internal Fixation of Distal Radius Fractures: A Prospective Randomized Trial
The purpose of this study is to compare early return to function in patients treated with closed reduction percutaneous pinning and open reduction internal fixation in displaced fractures of the distal radius.
Hypothesis: Wrist range of motion, grip strength and outcome at 2-3 months after injury are better in patients treated with open reduction, internal fixation (ORIF) than in patients treated with closed reduction percutaneous pinning techniques (CRPP). In addition patients treated with ORIF return to work at faster rates.
- Conditions
- Wrist Fractures
- Being tested
- CRPP, ORIF
- Keywords
- Return to Work, CRPP, ORIF, Distal Radius
- Medical subject headings
- Wrist Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CRPPProcedure or surgery
Closed reduction, percutaneous pinning
ORIFProcedure or surgery
Open reduction, internal fixation
| Study group | Role | What they receive |
|---|---|---|
| Operative (CRPP) | Active comparator | If indicated, the wrist fracture would be treated with surgery-the specific operative procedure would be randomized. Receives: Procedure: CRPP |
| Operative (ORIF) | Active comparator | If indicated, the wrist fracture would be treated with surgery-the specific operative procedure would be randomized Receives: Procedure: ORIF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wrist range of motion measurement. As well as recorded score from the DASH questionnaire.
Measured: 3 months post surgery
Secondary outcomes (1)
Range of motion measured in wrist and a scored DASH questionnaire
Measured: 1 year after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Wrist FracturesStudies of the same condition, open and under way.
- 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
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tamara Rozental, Beth Israel Deaconess Medical Center
- Investigators
- Tamara D Rozental, MD, Principal investigator, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00828685
- Sponsor's protocol ID
- 2005P000301
- Status last verified
- Feb 2017
- First submitted
- 13 Jan 2009
- Last updated
- 7 Feb 2017
- Results posted
- No
Publications
Rozental TD, Blazar PE, Franko OI, Chacko AT, Earp BE, Day CS. Functional outcomes for unstable distal radial fractures treated with open reduction and internal fixation or closed reduction and percutaneous fixation. A prospective randomized trial. J Bone Joint Surg Am. 2009 Aug;91(8):1837-46. doi: 10.2106/JBJS.H.01478.
PubMed 19651939
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Functional Outcomes After Closed Reduction Percutaneous Pinning vs. Open Reduction Internal Fixation of Distal Radius Fractures: A Prospective Randomized Trial
- ClinicalTrials.gov ID
- NCT00828685
- Acronym / sponsor ID
- 2005P000301
- Conditions
- Wrist Fractures
- Keywords
- Return to Work, CRPP, ORIF, Distal Radius
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- First posted
- 26 Jan 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.
The purpose of this study is to compare early return to function in patients treated with closed reduction percutaneous pinning and open reduction internal fixation in displaced fractures of the distal radius.
Hypothesis: Wrist range of motion, grip strength and outcome at 2-3 months after injury are better in patients treated with open reduction, internal fixation (ORIF) than in patients treated with closed reduction percutaneous pinning techniques (CRPP). In addition patients treated with ORIF return to work at faster rates.
Study design
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Operative (CRPP) | Active comparator | Procedure: CRPPIf indicated, the wrist fracture would be treated with surgery-the specific operative procedure would be randomized. |
| Operative (ORIF) | Active comparator | Procedure: ORIFIf indicated, the wrist fracture would be treated with surgery-the specific operative procedure would be randomized |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- 18 years or greater
- Patient functions independently
- Dorsally displaced, extra-articular fracture (Colles' fracture); or simple intra-articular fracture with a single split between the scaphoid and lunate facets.
- Isolated injury (no other injuries).
- One of the following criteria:
Key exclusion criteria (8 listed)
- More complex articular fractures (i.e. anything more than a simple sagittal split between the scaphoid and lunate facets).
- Volarly displaced fractures.
- Infirm patients.
- Patients that rely on others for basic functional activities.
- Open fractures
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 |
|---|---|---|
| CRPPClosed reduction, percutaneous pinning | Procedure or surgery | Operative (CRPP) |
| ORIFOpen reduction, internal fixation | Procedure or surgery | Operative (ORIF) |
Primary outcome
Wrist range of motion measurement. As well as recorded score from the DASH questionnaire.
Time frame: 3 months post surgery
1 secondary outcome
Range of motion measured in wrist and a scored DASH questionnaire
Time frame: 1 year after surgery
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 7 Feb 2017.
- Results publication: PubMed 19651939Rozental TD, Blazar PE, Franko OI, Chacko AT, Earp BE, Day CS. Functional outcomes for unstable distal radial fractures treated with open reduction and internal fixation or closed reduction and percutaneous fixation. A prospective randomized trial. J Bone Joint Surg Am. 2009 Aug;91(8):1837-46. doi: 10.2106/JBJS.H.01478.
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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.
Tamara D Rozental, MD principal investigator
Beth Israel Deaconess Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CRPP and ORIF in people with Wrist Fractures, run by Beth Israel Deaconess Medical Center 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 21 inclusion and 8 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 7 Feb 2017. 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 range of motion measurement. As well as recorded score from the DASH questionnaire. (time frame: 3 months post surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00828685, which also lists 1 linked publication.
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 7 Feb 2017.