NCT03701269

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 14, 2018

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 26, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

October 10, 2018

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 13, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 13, 2019

Completed
Last Updated

October 10, 2018

Status Verified

October 1, 2018

Enrollment Period

12 months

First QC Date

September 26, 2018

Last Update Submit

October 7, 2018

Conditions

Orthopedic

Keywords

Fracture

Outcome Measures

Primary Outcomes (1)

  • Disabilities of the Arm, Shoulder, and Hand (DASH) score

    30-item disability/symptom scale, scored 0 (no disability) to 100

    averaged 2 years

Secondary Outcomes (1)

  • Radiographic examination

    averaged 2 years

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Using arthroscopic or open fixation combined with bone graft surgery for proximal pole scaphoid nonunion

You may qualify if:

  • (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.

You may not qualify if:

  • (1) skeletally immature patients; (2) previous wrist trauma or surgery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taipei Veterans General Hospital

Taipei, 112, Taiwan

RECRUITING

MeSH Terms

Conditions

Fractures, Bone

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

  • Jung-Pan Wang, M.D.,ph.D

    Taipei Veterans General Hospital, Taiwan

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jung-Pan Wang, M.D.,ph.D

CONTACT

02-28757557jpwang801@gmail.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 26, 2018

First Posted

October 10, 2018

Study Start

August 14, 2018

Primary Completion

August 13, 2019

Study Completion

August 13, 2019

Last Updated

October 10, 2018

Record last verified: 2018-10

Locations

TW(1)