Distal Radius FracturesPhase 4NCT00205998
Surgical Plate Osteosynthesis of Distal Radius Fractures
A Phase 4 study testing Locking Compression Plate 2,4mm and Locking Compression Plate 3,5mm in people with Distal Radius Fractures, run by AO Clinical Investigation and Publishing Documentation at 3 sites in 3 countries.
Trial summary
Primary objective of the study is to demonstrate specific indications for the surgical treatment of distal radius fractures using the locking compression plate. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Distal Radius Fractures
- What is being tested?
- Locking Compression Plate 2,4mm and Locking Compression Plate 3,5mm
- Type of treatment
- Medical device
- How many people
- 450 participants
- Where
- 3 sitesin 3 countries
- Study dates
- Dec 2001to Dec 2005
- Phase
- Phase 4
- 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
- skeletally mature female and male
- Distal radius and ulnar fractures AO 23
- 10 days after injury
Who cannot join
- general or local conditions adversely affecting the bone physiology
- ISS >16
- osteosynthesis close to the wrist joint where a different implant has been used
- history of drug and alcohol abuse
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
About this study
Official title: Surgical Plate Osteosynthesis of Distal Radius Fractures. Prospective Study of the Locking Compression Plate (LCP)
Primary objective of the study is to demonstrate specific indications for the
surgical treatment of distal radius fractures using the locking compression
plate.
Read the detailed description
In addition the differences between the surgical treatment compared to
conservative treatment with respect to fracture healing, functional outcome
and subject satisfaction will be analysed after 6w./6m./1y./2y.
- Conditions
- Distal Radius Fractures
- Being tested
- Locking Compression Plate 2,4mm, Locking Compression Plate 3,5mm
- Keywords
- Locking Compression Plate, Conservative treatment, Surgical treatment, Radius fractures, AO 23
- Medical subject headings
- Wrist Fractures, Radius Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Locking Compression Plate 2,4mmDevice
Locking Compression Plate 3,5mmDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
- Document specific indications for the surgical treatment of distal radius fractures using the LCP
Secondary outcomes (4)
- Primary reduction and maintenance of reduction of the plate fixation
- Functional outcome scoring using "Garetland and Werley, DASH and SF-36 scoring
- Patient and surgeon satisfaction
- Analysis of the occured complications
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startDec 2001
- Study completionDec 2005
Why it stopped: Study completed
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Distal Radius 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 450 participants (actual)
Sponsor and investigators
- Lead sponsor
- AO Clinical Investigation and Publishing Documentation
- Sponsor type
- University, hospital or other
- Collaborators
- Synthes Inc., AO Hand Expert Group
- Investigators
- Andreas W Wentzensen, Prof. MD, Principal investigator, BG-Unfallklinik LudwigshafenJesse B Jupiter, Prof. MD, Principal investigator, Harvard Medical School (HMS and HSDM)Peter G De Boer, F.R.C.S., Principal investigator, York District Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00205998
- Sponsor's protocol ID
- 01-LCP2,4/3,5-03
- Status last verified
- Apr 2007
- First submitted
- 13 Sep 2005
- Last updated
- 27 Apr 2007
- Results posted
- No
- Data monitoring committee
- 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
- Surgical Plate Osteosynthesis of Distal Radius Fractures. Prospective Study of the Locking Compression Plate (LCP)
- ClinicalTrials.gov ID
- NCT00205998
- Acronym / sponsor ID
- 01-LCP2,4/3,5-03
- Conditions
- Distal Radius Fractures
- Keywords
- Locking Compression Plate, Conservative treatment, Surgical treatment, Radius fractures, AO 23
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study completed
- Enrolment
- 450 participants (actual)
- Lead sponsor
- AO Clinical Investigation and Publishing DocumentationUniversity, hospital or other
- Collaborators
- Synthes Inc., AO Hand Expert Group
- Study start
- Dec 2001
- Study completion
- Dec 2005 (actual)
- First posted
- 21 Sep 2005 (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.
Primary objective of the study is to demonstrate specific indications for the
surgical treatment of distal radius fractures using the locking compression
plate.
Detailed description
In addition the differences between the surgical treatment compared to
conservative treatment with respect to fracture healing, functional outcome
and subject satisfaction will be analysed after 6w./6m./1y./2y.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- skeletally mature female and male
- Distal radius and ulnar fractures AO 23
- 10 days after injury
Key exclusion criteria (4 listed)
- general or local conditions adversely affecting the bone physiology
- ISS >16
- osteosynthesis close to the wrist joint where a different implant has been used
- history of drug and alcohol abuse
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 |
|---|---|---|
| Locking Compression Plate 2,4mm | Device | – |
| Locking Compression Plate 3,5mm | Device | – |
Primary outcome
- Document specific indications for the surgical treatment of distal radius fractures using the LCP
4 secondary outcomes
- Primary reduction and maintenance of reduction of the plate fixation
- Functional outcome scoring using "Garetland and Werley, DASH and SF-36 scoring
- Patient and surgeon satisfaction
- Analysis of the occured complications
Results and safety
The study was stopped early (reason given: Study completed). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2007.
Related trials for Distal Radius Fractures
Recruiting
No Reduction Compared to Closed Reduction for Distal Radius Fractures in Patients Over 65 or Older
Distal Radius Fracture, Casting
Active, not recruiting
Immediate Mobilization Versus 2 Weeks Cast Immobilization After Distal Radius Fracture Treated With Volar Locking Plate
Distal Radius Fracture
Recruiting
Wrist Injury Strengthening Exercise (WISE) Versus Usual Care Advice for Improving Pain and Function
Distal Radius Fracture, Colles Fracture
Not yet recruiting
One Inch Punch High Impact Training Randomized Control Trial (1'' Punch HIT RCT)
Distal Radius Fracture
Not yet recruiting
Magnesium Alloy Scaffold With Controlled Degradation for Periarticular Bone Defects
Periarticular Bone Defect, Proximal Humerus Fracture
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.
Andreas W Wentzensen, Prof. MD principal investigator
BG-Unfallklinik Ludwigshafen
Jesse B Jupiter, Prof. MD principal investigator
Harvard Medical School (HMS and HSDM)
Peter G De Boer, F.R.C.S. principal investigator
York District Hospital
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Locking Compression Plate 2,4mm and Locking Compression Plate 3,5mm in people with Distal Radius Fractures, run by AO Clinical Investigation and Publishing Documentation at 3 sites in 3 countries.
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 4 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: stopped early, 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 3 sites in United States, Germany, United Kingdom. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Study completed). Results are not available in the source record.
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?
- Document specific indications for the surgical treatment of distal radius fractures using the LCP. 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.