Triangular Fibrocartilage Complex InjuriesNCT01145716
Exploration of Wrist Soft Tissue Injuries Associated With Wrist Fractures
A study testing Arthroscopy, surgery in people with Triangular Fibrocartilage Complex Injuries, run by Linkoeping University at 1 site in Sweden.
Trial summary
The purpose of this study is to describe and stage lesions of the triangular fibrocartilage complex (TFCC) in association with distal radius fractures. 20 patients with dorsally dislocated AO type A fractures of the distal radius with sufficient displacement (based of cadaveric data) will be included. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Triangular Fibrocartilage Complex Injuries
- What is being tested?
- Arthroscopy, surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSweden
- Study dates
- Aug 2009to May 2011
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-65
- Distal radius fracture
- Displacement > 20 degrees of dorsal angulation
Who cannot join
- Previous significant wrist injury
- Declines to participate
- Ulnar styloid fracture at base or proximal to it
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Exploration of Acute TFCC-injuries in Association With Distal Radius Fractures
The purpose of this study is to describe and stage lesions of the triangular fibrocartilage complex (TFCC) in association with distal radius fractures. 20 patients with dorsally dislocated AO type A fractures of the distal radius with sufficient displacement (based of cadaveric data) will be included. After stability testing and wrist arthroscopy. The TFCC is explored through a volar incision and injuries were documented and repaired from this approach.
- Being tested
- Arthroscopy, surgery
- Keywords
- TFCC injuries, Distal radius fractures
- Medical subject headings
- Wrist Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arthroscopy, surgeryProcedure or surgery
Ulno-volar wrist approach to the TFCC
| Study group | Role | What they receive |
|---|---|---|
| Surgical exploration | Other | Descriptive Receives: Procedure: Arthroscopy, surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Residual instability symptoms
Mechanisms of injury are poorly previously described. This study will hopefully confirm cadeveric data. There is some evidence that patients might benefit from acute repair. Residual instability can be both ulnocarpal and radioulnar.
Measured: Approx 2-6 months to include the patients that meet the inclusion criteria. They will be followed for 6 momths
Secondary outcomes (1)
Adverse events
Patients that accept to participate will undergo exploration from a (new) ulnovolar approach. The study is purely descriptive. Patients are monitored for adverse events such as nerve injury and infection for 3 months.
Measured: Three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2010 (estimated)
- Study startAug 2009
- Primary completionMay 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Triangular Fibrocartilage Complex InjuriesStudies of the same condition, open and under way.
- More trials run by Linkoeping UniversityThe 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Linkoeping University
- Sponsor type
- Other government
- Investigators
- Lars E Adolfsson, Assoc prof, Principal investigator, Linkopeing University, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01145716
- Sponsor's protocol ID
- OC Linkoping TFCC volar expl
- Other IDs
- Dnr M200-08 Linkoping
- Status last verified
- Nov 2009
- First submitted
- 4 May 2010
- Last updated
- 20 May 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Lindau T, Hagberg L, Adlercreutz C, Jonsson K, Aspenberg P. Distal radioulnar instability is an independent worsening factor in distal radial fractures. Clin Orthop Relat Res. 2000 Jul;(376):229-35. doi: 10.1097/00003086-200007000-00031.
PubMed 10906880Lindau T, Arner M, Hagberg L. Intraarticular lesions in distal fractures of the radius in young adults. A descriptive arthroscopic study in 50 patients. J Hand Surg Br. 1997 Oct;22(5):638-43. doi: 10.1016/s0266-7681(97)80364-6.
PubMed 9752922Geissler WB, Fernandez DL, Lamey DM. Distal radioulnar joint injuries associated with fractures of the distal radius. Clin Orthop Relat Res. 1996 Jun;(327):135-46. doi: 10.1097/00003086-199606000-00018.
PubMed 8641057
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploration of Acute TFCC-injuries in Association With Distal Radius Fractures
- ClinicalTrials.gov ID
- NCT01145716
- Acronym / sponsor ID
- OC Linkoping TFCC volar expl
- Keywords
- TFCC injuries, Distal radius fractures
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Linkoeping UniversityOther government
- Study start
- Aug 2009
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 17 Jun 2010 (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 describe and stage lesions of the triangular fibrocartilage complex (TFCC) in association with distal radius fractures. 20 patients with dorsally dislocated AO type A fractures of the distal radius with sufficient displacement (based of cadaveric data) will be included. After stability testing and wrist arthroscopy. The TFCC is explored through a volar incision and injuries were documented and repaired from this approach.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Surgical exploration | Other | Procedure: Arthroscopy, surgeryDescriptive |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18-65
- Distal radius fracture
- Displacement > 20 degrees of dorsal angulation
Key exclusion criteria (3 listed)
- Previous significant wrist injury
- Declines to participate
- Ulnar styloid fracture at base or proximal to it
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 |
|---|---|---|
| Arthroscopy, surgeryUlno-volar wrist approach to the TFCC | Procedure or surgery | Surgical exploration |
Primary outcome
Residual instability symptoms
Time frame: Approx 2-6 months to include the patients that meet the inclusion criteria. They will be followed for 6 momths
Mechanisms of injury are poorly previously described. This study will hopefully confirm cadeveric data. There is some evidence that patients might benefit from acute repair. Residual instability can be both ulnocarpal and radioulnar.
1 secondary outcome
Adverse events
Time frame: Three months
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 20 May 2011.
- Background: PubMed 10906880Lindau T, Hagberg L, Adlercreutz C, Jonsson K, Aspenberg P. Distal radioulnar instability is an independent worsening factor in distal radial fractures. Clin Orthop Relat Res. 2000 Jul;(376):229-35. doi: 10.1097/00003086-200007000-00031.
- Background: PubMed 9752922Lindau T, Arner M, Hagberg L. Intraarticular lesions in distal fractures of the radius in young adults. A descriptive arthroscopic study in 50 patients. J Hand Surg Br. 1997 Oct;22(5):638-43. doi: 10.1016/s0266-7681(97)80364-6.
- Background: PubMed 8641057Geissler WB, Fernandez DL, Lamey DM. Distal radioulnar joint injuries associated with fractures of the distal radius. Clin Orthop Relat Res. 1996 Jun;(327):135-46. doi: 10.1097/00003086-199606000-00018.
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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.
Lars E Adolfsson, Assoc prof principal investigator
Linkopeing University, Sweden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arthroscopy, surgery in people with Triangular Fibrocartilage Complex Injuries, run by Linkoeping University at 1 site in Sweden.
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 3 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 20 May 2011. 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 Sweden. 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?
Residual instability symptoms (time frame: Approx 2-6 months to include the patients that meet the inclusion criteria. They will be followed for 6 momths). 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 NCT01145716, which also lists 3 linked publications.
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 20 May 2011.