Colles' FractureNCT00271726
Operative Treatment of Extraarticular Colles' Fractures of the Distal Radius (OTEC)
A study testing Osteosynthesis with palmar locking plate, Osteosynthesis with external fixator and Osteosynthesis with Kirschner wires in people with Colles' Fracture and Radius Fractures, run by Heinrich-Heine University, Duesseldorf at 1 site in Germany.
Trial summary
This is a prospective, randomized, multi-center pilot study of unstable extraarticular fractures of the distal radius with dorsal displacement of the distal fragment in elderly patients. The patients are randomly assigned to osteosynthesis with palmar locking plate, external fixator, or Kirschner wires. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Colles' Fracture, Radius Fractures
- What is being tested?
- Osteosynthesis with palmar locking plate, Osteosynthesis with external fixator and Osteosynthesis with Kirschner wires
- Type of treatment
- Surgery or procedure
- How many people
- 90 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2005to 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Isolated, extraarticular, unstable Colles' fracture of the metaphysis of the distal radius (AO type A3)
- Age 65 years or older
- Patient agreed with and signed the "informed consent" form
Who cannot join
- Fractures older than 7 days (more than 1 week between injury and treatment)
- Other injuries of the hand
- Other relevant injuries of the upper extremities
- Open fracture
- Patients with one hand missing
- Clinical or radiological signs of any rheumatoid disease, osteoarthritis, or polyarthritis
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- Previous skeletal injury or severe soft tissue injury of the arm
- History of drug or alcohol abuse
- Patients unlikely to cooperate or attend all scheduled visits
- Patients who have participated in any other device or drug clinical trial within the previous month
- Patients with legal incompetence
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Department of Trauma and Hand Surgery, University Hospital
Düsseldorf, D - 40225
Michael Schädel-Höpfner, MD, +49 211 8104405, schaedel@uni-duesseldorf.de
Michael Schädel-Höpfner, MD
About this study
Official title: Prospective, Randomized, Multi-Center Pilot Study on the Treatment of Unstable, Extraarticular Colles Fractures of the Distal Radius by Palmar Locking Plate, External Fixator or Kirschner Wires
This is a prospective, randomized, multi-center pilot study of unstable extraarticular fractures of the distal radius with dorsal displacement of the distal fragment in elderly patients. The patients are randomly assigned to osteosynthesis with palmar locking plate, external fixator, or Kirschner wires.
The aim of this pilot study is to allow a sample size calculation for a main randomized controlled trial (RCT). The primary outcome criterion is the functional status measured by the Disability of the Arm, Shoulder and Hand (DASH) questionnaire. Secondary outcome criteria are pain, range of motion (ROM), grip strength, and radiological parameters. Since this is a pilot study it is intended to generate a study hypothesis for the main RCT.
- Conditions
- Colles' Fracture, Radius Fractures
- Being tested
- Osteosynthesis with palmar locking plate, Osteosynthesis with external fixator, Osteosynthesis with Kirschner wires
- Keywords
- distal radius fracture, extraarticular Colles fracture
- Medical subject headings
- Colles' Fracture, Radius Fractures, Wrist Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Osteosynthesis with palmar locking plateProcedure or surgery
Osteosynthesis with external fixatorProcedure or surgery
Osteosynthesis with Kirschner wiresProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional status measured by DASH questionnaire
Secondary outcomes (5)
Pain
Range of motion (ROM)
Grip strength
Radiological parameters
Feasibility
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2006 (estimated)
- Study startNov 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colles' FractureStudies of the same condition, open and under way.
- More trials run by Heinrich-Heine University, DuesseldorfThe 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
- 90 participants
Sponsor and investigators
- Lead sponsor
- Heinrich-Heine University, Duesseldorf
- Sponsor type
- University, hospital or other
- Collaborators
- Philipps University Marburg
- Investigators
- Michael Schädel-Höpfner, MD, Principal investigator, Department of Trauma and Hand Surgery, University Hospital, Moorenstrasse 5, D - 40225 Düsseldorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00271726
- Sponsor's protocol ID
- OTEC Pilot 1 KKS MR
- Status last verified
- Apr 2007
- First submitted
- 3 Jan 2006
- Last updated
- 27 Apr 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Randomized, Multi-Center Pilot Study on the Treatment of Unstable, Extraarticular Colles Fractures of the Distal Radius by Palmar Locking Plate, External Fixator or Kirschner Wires
- ClinicalTrials.gov ID
- NCT00271726
- Acronym / sponsor ID
- OTEC Pilot 1 KKS MR
- Conditions
- Colles' Fracture, Radius Fractures
- Keywords
- distal radius fracture, extraarticular Colles fracture
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants
- Lead sponsor
- Heinrich-Heine University, DuesseldorfUniversity, hospital or other
- Collaborators
- Philipps University Marburg
- Study start
- Nov 2005
- First posted
- 4 Jan 2006 (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.
This is a prospective, randomized, multi-center pilot study of unstable extraarticular fractures of the distal radius with dorsal displacement of the distal fragment in elderly patients. The patients are randomly assigned to osteosynthesis with palmar locking plate, external fixator, or Kirschner wires.
The aim of this pilot study is to allow a sample size calculation for a main randomized controlled trial (RCT). The primary outcome criterion is the functional status measured by the Disability of the Arm, Shoulder and Hand (DASH) questionnaire. Secondary outcome criteria are pain, range of motion (ROM), grip strength, and radiological parameters. Since this is a pilot study it is intended to generate a study hypothesis for the main RCT.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Isolated, extraarticular, unstable Colles' fracture of the metaphysis of the distal radius (AO type A3)
- Age 65 years or older
- Patient agreed with and signed the "informed consent" form
Key exclusion criteria (11 listed)
- Fractures older than 7 days (more than 1 week between injury and treatment)
- Other injuries of the hand
- Other relevant injuries of the upper extremities
- Open fracture
- Patients with one hand missing
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 |
|---|---|---|
| Osteosynthesis with palmar locking plate | Procedure or surgery | – |
| Osteosynthesis with external fixator | Procedure or surgery | – |
| Osteosynthesis with Kirschner wires | Procedure or surgery | – |
Primary outcome
Functional status measured by DASH questionnaire
5 secondary outcomes
Pain
Range of motion (ROM)
Grip strength
Radiological parameters
Feasibility
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2007.
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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.
Michael Schädel-Höpfner, MD principal investigator
Department of Trauma and Hand Surgery, University Hospital, Moorenstrasse 5, D - 40225 Düsseldorf
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Osteosynthesis with palmar locking plate, Osteosynthesis with external fixator and Osteosynthesis with Kirschner wires in people with Colles' Fracture and Radius Fractures, run by Heinrich-Heine University, Duesseldorf at 1 site in Germany.
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 3 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 27 Apr 2007. 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 Germany. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michael Schädel-Höpfner, MD (+49 211 8104405, schaedel@uni-duesseldorf.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional status measured by DASH questionnaire. 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 27 Apr 2007.