OrthopedicNCT03701269
Long-term Surgical Outcomes of Scaphoid Proximal Pole Fracture Nonunion
An observational study of Orthopedic, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
Trial summary
The treatment for scaphoid proximal pole nonunion remains challenging due to the poor vascularity in the proximal pole fragment, associated SL injury and the technique of fixation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Orthopedic
- How many people
- 10 participants
- Where
- 1 siteTaiwan
- Study dates
- 14 Aug 2018to 13 Aug 2019
- Phase
- Observational
- 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
Study population: Using arthroscopic or open fixation combined with bone graft surgery for proximal pole scaphoid nonunion
Who may be able to join
- (1) chronic nonunion (wrist pain for more than 3 months after injury) as defined by preoperative radiographs; and (2) combined positive SL instability measured by intraoperative arthroscopy exam test; (3) Grade I SNAC.
Who cannot join
- (1) skeletally immature patients; (2) previous wrist trauma or surgery.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Taipei Veterans General Hospital
Taipei, 112
Jung-Pan Wang, M.D.,ph.D, 0228712121 ext. 1125, jpwang801@gmail.com
About this study
Official title: Long-term Radiographic and Clinic Surgical Outcomes of Scaphoid Proximal Pole Fracture Nonunion
The treatment for scaphoid proximal pole nonunion remains challenging due to the poor vascularity in the proximal pole fragment, associated SL injury and the technique of fixation. Vascularized bone grafts and non-vascularized iliac bone graft have been used in patients with scaphoid proximal pole nonunion, but the indication has not been well clarified. Alternatively, we have been treating such patients with vascularized bone graft , or non-vascularized bone graft with screw or k-wire fixation with considerable success. The purpose of this study is to evaluate and analyze retrospectively the surgical efficacy of our procedure.
Read the detailed description
Scaphoid nonunion are common and operative treatment with bone graft was reported to have good result. However, the treatment for proximal pole nonunion remains controversial. There are some patterns of pathoanatomy combined with scaphoid fracture, like SL ligament tears, which could not be easily identified or treated initially. The proximal pole nonunion was near SL joint. Therefore, proximal pole nonunion may result in DISI instability. Furthermore, proximal pole nonunion was identified as a poor prognostic factor in scaphoid nonunion.
In the past 10 years, we have some different technique, like VBG, arthroscopic bone graft to achieve good results. Some studies revealed that significantly better SL stability was achieved with ARASL. We also used ARASL with BG to improve proximal pole union. However, it is not clear which method would be appropriate for proximal pole nonunion. We retrospectively investigated the functional outcome and radiological results after at least 2-year follow-up to clarify the surgical efficacy of these procedures.
- Conditions
- Orthopedic
- Keywords
- Fracture
- Medical subject headings
- Fractures, Bone
What is being measured
The primary outcome is the main question the study is designed to answer.
Disabilities of the Arm, Shoulder, and Hand (DASH) score
30-item disability/symptom scale, scored 0 (no disability) to 100
Measured: averaged 2 years
Secondary outcomes (1)
Radiographic examination
The union was defined as trabecular bridging across the fracture site
Measured: averaged 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2018
- Study start14 Aug 2018
- Primary completion13 Aug 2019 (estimated)
- Study completion13 Aug 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OrthopedicStudies of the same condition, open and under way.
- More trials run by Taipei Veterans General Hospital, TaiwanThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Veterans General Hospital, Taiwan
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Jung-Pan Wang, M.D.,ph.D, Principal investigator, Taipei Veterans General Hospital, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03701269
- Sponsor's protocol ID
- 2018-08-010AC
- Status last verified
- Oct 2018
- First submitted
- 26 Sep 2018
- Last updated
- 10 Oct 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Radiographic and Clinic Surgical Outcomes of Scaphoid Proximal Pole Fracture Nonunion
- ClinicalTrials.gov ID
- NCT03701269
- Acronym / sponsor ID
- 2018-08-010AC
- Conditions
- Orthopedic
- Keywords
- Fracture
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Taipei Veterans General Hospital, TaiwanOther government
- Study start
- 14 Aug 2018 (actual)
- Primary completion
- 13 Aug 2019 (estimated)
- Study completion
- 13 Aug 2019 (estimated)
- First posted
- 10 Oct 2018 (actual)
- 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 treatment for scaphoid proximal pole nonunion remains challenging due to the poor vascularity in the proximal pole fragment, associated SL injury and the technique of fixation. Vascularized bone grafts and non-vascularized iliac bone graft have been used in patients with scaphoid proximal pole nonunion, but the indication has not been well clarified. Alternatively, we have been treating such patients with vascularized bone graft , or non-vascularized bone graft with screw or k-wire fixation with considerable success. The purpose of this study is to evaluate and analyze retrospectively the surgical efficacy of our procedure.
Detailed description
Scaphoid nonunion are common and operative treatment with bone graft was reported to have good result. However, the treatment for proximal pole nonunion remains controversial. There are some patterns of pathoanatomy combined with scaphoid fracture, like SL ligament tears, which could not be easily identified or treated initially. The proximal pole nonunion was near SL joint. Therefore, proximal pole nonunion may result in DISI instability. Furthermore, proximal pole nonunion was identified as a poor prognostic factor in scaphoid nonunion.
In the past 10 years, we have some different technique, like VBG, arthroscopic bone graft to achieve good results. Some studies revealed that significantly better SL stability was achieved with ARASL. We also used ARASL with BG to improve proximal pole union. However, it is not clear which method would be appropriate for proximal pole nonunion. We retrospectively investigated the functional outcome and radiological results after at least 2-year follow-up to clarify the surgical efficacy of these procedures.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Using arthroscopic or open fixation combined with bone graft surgery for proximal pole scaphoid nonunion
Key inclusion criteria (1 listed)
- (1) chronic nonunion (wrist pain for more than 3 months after injury) as defined by preoperative radiographs; and (2) combined positive SL instability measured by intraoperative arthroscopy exam test; (3) Grade I SNAC.
Key exclusion criteria (1 listed)
- (1) skeletally immature patients; (2) previous wrist trauma or surgery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Disabilities of the Arm, Shoulder, and Hand (DASH) score
Time frame: averaged 2 years
30-item disability/symptom scale, scored 0 (no disability) to 100
1 secondary outcome
Radiographic examination
Time frame: averaged 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2018.
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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.
Jung-Pan Wang, M.D.,ph.D principal investigator
Taipei Veterans General Hospital, Taiwan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Orthopedic, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
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 1 inclusion and 1 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 10 Oct 2018. 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 Taiwan. 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 Jung-Pan Wang, M.D.,ph.D (02-28757557 ext. 1125, jpwang801@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disabilities of the Arm, Shoulder, and Hand (DASH) score (time frame: averaged 2 years). 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 10 Oct 2018.