Operative TimeADTPDNCT00738127
Safety Study of Surgical Technique to Treat Acute Dorsal Trans-Scaphoid Perilunate Dislocations
A study testing Open reduction and internal fixation in people with Operative Time and Grip Strength, run by The Second Hospital of Qinhuangdao at 1 site in China.
Trial summary
The purpose of this study is to determine a surgical technique is effective in the treatment of acute dorsal trans-scaphoid perilunate dislocations. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Operative Time, Grip Strength, Pain
- What is being tested?
- Open reduction and internal fixation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 801 participants
- Where
- 1 siteChina
- Study dates
- Oct 1992to Oct 2004
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Clinical treatment of acute trans-scaphoid perilunate dislocations
- Must have open reduction and internal fixation
Who cannot join
- Patients whose age under 18 years
- Associated with severe crush, avulsion, or opened injury
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Surgical Techniques for Acute Dorsal Trans-Scaphoid Perilunate Dislocations
The purpose of this study is to determine a surgical technique is effective in the treatment of acute dorsal trans-scaphoid perilunate dislocations.
Read the detailed description
Open reduction and internal fixation is an effective method of treating acute trans-scaphoid perilunate dislocations. We study a new surgical technique that allows for early wrist excises postoperatively. We compare this technique to Inoue et al. 's techniques affect the objective and subjective outcomes. We also compared the long-term outcomes of these two procedures performed in similar patient groups.Although both groups had satisfactory results with regard to their pain relief, sufficient grip strength and union of scaphoid fracture, the technique using in group I was more easily and quickly to perform. It allows early postoperative excises and results better functional wrist range of motion.
- Conditions
- Operative Time, Grip Strength, Pain, Functional Status
- Being tested
- Open reduction and internal fixation
- Keywords
- Acute trans-scaphoid perilunate dislocations, Open reduction and internal fixation, Kirschner-wire, Range of motion
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Open reduction and internal fixationProcedure or surgery
Also called Techniques for Perilunate Dislocations
Inoue et al.'s technique is most commonly used which required placing three K-wires to immobilize both midcarpal joint and radiocarpal joint. This technique is effective, however, it has some problems. In the study, we improve the surgical technique.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Group I (treatment with our technique) Eighteen patients (18 wrists) were available for long-term follow-up at an average of 47.8 months after surgery. There were 11 men and seven women. Their mean age at the time of surgery was 35.4 years (range, 22 to 56 years). The dominant hand was involved in 12 patients and the nondominant hand, in six. Receives: Procedure: Open reduction and internal fixation |
| 2 | Experimental | Group II (treatment with Inoue et al.'s technique) Fifteen patients (15 wrists) were evaluated at an average of 51 months. Nine patients were men and 6 were women. The mean age of the group at the time of surgery was 37.5 years (range, 24 to 58 years). The dominant hand was involved in 10 and nondominant hand, in seven. Receives: Procedure: Open reduction and internal fixation |
What is being measured
The primary outcome is the main question the study is designed to answer.
In group I was more easily and quickly to perform. It allows early postoperative excises and results better functional wrist range of motion.
Measured: 1992-2004
Secondary outcomes (1)
Both groups had satisfactory results with regard to their pain relief, sufficient grip strength and union of scaphoid fracture.
Measured: 1992-2004
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2008 (estimated)
- Study startOct 1992
- Primary completionJun 2004
- Study completionOct 2004
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 Operative TimeStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 801 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Second Hospital of Qinhuangdao
- Sponsor type
- University, hospital or other
- Investigators
- Xu Zhang, MD, Study chair, The Second Hospital of Qinhuangdao
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00738127
- Sponsor's protocol ID
- SHQ-0808-A
- Acronym
- ADTPD
- Status last verified
- Aug 2008
- First submitted
- 15 Aug 2008
- Last updated
- 20 Aug 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Moneim MS, Hofammann KE 3rd, Omer GE. Transscaphoid perilunate fracture-dislocation. Result of open reduction and pin fixation. Clin Orthop Relat Res. 1984 Nov;(190):227-35.
PubMed 6386257
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgical Techniques for Acute Dorsal Trans-Scaphoid Perilunate Dislocations
- ClinicalTrials.gov ID
- NCT00738127
- Acronym / sponsor ID
- ADTPD / SHQ-0808-A
- Conditions
- Operative Time, Grip Strength, Pain, Functional Status
- Keywords
- Acute trans-scaphoid perilunate dislocations, Open reduction and internal fixation, Kirschner-wire, Range of motion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 801 participants (actual)
- Lead sponsor
- The Second Hospital of QinhuangdaoUniversity, hospital or other
- Study start
- Oct 1992
- Primary completion
- Jun 2004 (actual)
- Study completion
- Oct 2004 (actual)
- First posted
- 20 Aug 2008 (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 determine a surgical technique is effective in the treatment of acute dorsal trans-scaphoid perilunate dislocations.
Detailed description
Open reduction and internal fixation is an effective method of treating acute trans-scaphoid perilunate dislocations. We study a new surgical technique that allows for early wrist excises postoperatively. We compare this technique to Inoue et al. 's techniques affect the objective and subjective outcomes. We also compared the long-term outcomes of these two procedures performed in similar patient groups.Although both groups had satisfactory results with regard to their pain relief, sufficient grip strength and union of scaphoid fracture, the technique using in group I was more easily and quickly to perform. It allows early postoperative excises and results better functional wrist range of motion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: Open reduction and internal fixationGroup I (treatment with our technique) Eighteen patients (18 wrists) were available for long-term follow-up at an average of 47.8 months after surgery. There were 11 men and seven women. Their mean age at the time of surgery was 35.4 years (range, 22 to 56 years). The dominant hand was involved in 12 patients and the nondominant hand, in six. |
| 2 | Experimental | Procedure: Open reduction and internal fixationGroup II (treatment with Inoue et al.'s technique) Fifteen patients (15 wrists) were evaluated at an average of 51 months. Nine patients were men and 6 were women. The mean age of the group at the time of surgery was 37.5 years (range, 24 to 58 years). The dominant hand was involved in 10 and nondominant hand, in seven. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Clinical treatment of acute trans-scaphoid perilunate dislocations
- Must have open reduction and internal fixation
Key exclusion criteria (2 listed)
- Patients whose age under 18 years
- Associated with severe crush, avulsion, or opened injury
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 |
|---|---|---|
| Open reduction and internal fixationAlso: Techniques for Perilunate DislocationsInoue et al.'s technique is most commonly used which required placing three K-wires to immobilize both midcarpal joint and radiocarpal joint. This technique is effective, however, it has some problems. In the study, we improve the surgical technique. | Procedure or surgery | 1, 2 |
Primary outcome
In group I was more easily and quickly to perform. It allows early postoperative excises and results better functional wrist range of motion.
Time frame: 1992-2004
1 secondary outcome
Both groups had satisfactory results with regard to their pain relief, sufficient grip strength and union of scaphoid fracture.
Time frame: 1992-2004
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 Aug 2008.
- Background: PubMed 6386257Moneim MS, Hofammann KE 3rd, Omer GE. Transscaphoid perilunate fracture-dislocation. Result of open reduction and pin fixation. Clin Orthop Relat Res. 1984 Nov;(190):227-35.
- Treatment of trans-scaphoid perilunate dislocations by internal fixation with the Herbert screwLink provided by the sponsor.
- Perilunate DislocationsLink provided by the sponsor.
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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.
Xu Zhang, MD study chair
The Second Hospital of Qinhuangdao
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Open reduction and internal fixation in people with Operative Time and Grip Strength, run by The Second Hospital of Qinhuangdao at 1 site in China.
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 2 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 Aug 2008. 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 China. 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?
In group I was more easily and quickly to perform. It allows early postoperative excises and results better functional wrist range of motion. (time frame: 1992-2004). 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 NCT00738127, 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 20 Aug 2008.