Scaphoid FracturePhase 4NCT00205985
Operative Versus Conservative Treatment of Scaphoid Fractures
A Phase 4 study testing Scaphoid screw in people with Scaphoid Fracture, run by AO Clinical Investigation and Publishing Documentation at 1 site in Germany.
Trial summary
The aim of this study is to compare the time to return to previous activity level between operative treatment and non-operative cast immobilization of patients with an acute complete fracture of the middle part of the scaphoid, without any dislocation or comminution visible CT-scan. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Scaphoid Fracture
- What is being tested?
- Scaphoid screw
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteGermany
- Study dates
- Dec 2003to Apr 2006
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Mature skeleton
- Isolated, acute complete fracture of the mid third of the scaphoid
Who cannot join
- acute fractures of both hands
- one hand missing
- other injuries than scaphoid fractures
- rheumatoid, osteoarthritis or polyarthritis
- previous soft tissue injuries of the hand
- drug or alcohol abuse
- participant in trial during the previous month
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Time to Return to Previous Activity Between Operative Treatment and Cast Immobilization of Complete Fracture of the Middle Part of the Scaphoid Without Dislocation
The aim of this study is to compare the time to return to previous activity
level between operative treatment and non-operative cast immobilization of
patients with an acute complete fracture of the middle part of the scaphoid,
without any dislocation or comminution visible CT-scan.
- Conditions
- Scaphoid Fracture
- Being tested
- Scaphoid screw
- Keywords
- Return to work, Scaphoid fracture, Operative treatment, Activity level
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Scaphoid screwDevice
Conservative treatment versus application of scaphoid screw
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to return to previous activity level
Time to return to full work and household duties
Secondary outcomes (2)
DASH
SF-36
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 2003
- Study completionApr 2006
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 Scaphoid FractureStudies 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
- 100 participants
Sponsor and investigators
- Lead sponsor
- AO Clinical Investigation and Publishing Documentation
- Sponsor type
- University, hospital or other
- Investigators
- Markus Schaedel-Hoepfner, Prof. MD, Principal investigator, Klinikum der Universitaet Marburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00205985
- Sponsor's protocol ID
- 03-scaph-04
- Status last verified
- Aug 2020
- First submitted
- 14 Sep 2005
- Last updated
- 14 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Pfeiffer BM, Nubling M, Siebert HR, Schadel-Hopfner M. A prospective multi-center cohort study of acute non-displaced fractures of the scaphoid: operative versus non-operative treatment [NCT00205985]. BMC Musculoskelet Disord. 2006 May 11;7:41. doi: 10.1186/1471-2474-7-41.
PubMed 16689987
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Time to Return to Previous Activity Between Operative Treatment and Cast Immobilization of Complete Fracture of the Middle Part of the Scaphoid Without Dislocation
- ClinicalTrials.gov ID
- NCT00205985
- Acronym / sponsor ID
- 03-scaph-04
- Conditions
- Scaphoid Fracture
- Keywords
- Return to work, Scaphoid fracture, Operative treatment, Activity level
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants
- Lead sponsor
- AO Clinical Investigation and Publishing DocumentationUniversity, hospital or other
- Study start
- Dec 2003
- Study completion
- Apr 2006 (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.
The aim of this study is to compare the time to return to previous activity
level between operative treatment and non-operative cast immobilization of
patients with an acute complete fracture of the middle part of the scaphoid,
without any dislocation or comminution visible CT-scan.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Mature skeleton
- Isolated, acute complete fracture of the mid third of the scaphoid
Key exclusion criteria (7 listed)
- acute fractures of both hands
- one hand missing
- other injuries than scaphoid fractures
- rheumatoid, osteoarthritis or polyarthritis
- previous soft tissue injuries of the hand
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 |
|---|---|---|
| Scaphoid screwConservative treatment versus application of scaphoid screw | Device | – |
Primary outcome
Time to return to previous activity level
Time to return to full work and household duties
2 secondary outcomes
DASH
SF-36
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 14 Aug 2020.
- Results publication: PubMed 16689987Pfeiffer BM, Nubling M, Siebert HR, Schadel-Hopfner M. A prospective multi-center cohort study of acute non-displaced fractures of the scaphoid: operative versus non-operative treatment [NCT00205985]. BMC Musculoskelet Disord. 2006 May 11;7:41. doi: 10.1186/1471-2474-7-41.
Related trials for Scaphoid Fracture
Recruiting
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Medial Malleolus Fracture, Lisfranc Injury
Recruiting
Arthroscopic vs. Open Bone Grafting for Scaphoid Delayed/Nonunion
Scaphoid Fracture, Scaphoid Nonunion
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.
Markus Schaedel-Hoepfner, Prof. MD principal investigator
Klinikum der Universitaet Marburg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Scaphoid screw in people with Scaphoid Fracture, run by AO Clinical Investigation and Publishing Documentation 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 2 inclusion and 7 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 14 Aug 2020. 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.
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 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?
Time to return to previous activity level. The study lists 2 primary outcomes in all. 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 NCT00205985, 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 14 Aug 2020.