Long-term Surgical Outcomes of Scaphoid Proximal Pole Fracture Nonunion

Orthopedic Clinical Trial

Official title:

Long-term Radiographic and Clinic Surgical Outcomes of Scaphoid Proximal Pole Fracture Nonunion

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03701269
• Other study ID #: 2018-08-010AC
• Status: Recruiting
• Start date: August 14, 2018
• Est. completion date: August 13, 2019

Study information

• Verified date: October 2018
• Source: Taipei Veterans General Hospital, Taiwan
• Contact: Jung-Pan Wang, M.D.,ph.D
• Phone: 02-28757557
• Email: jpwang801[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: August 13, 2019
• Est. primary completion date: August 13, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• (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.

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Fractures, Ununited
• Orthopedic

Locations

Country	Name	City	State
Taiwan	Taipei Veterans General Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Veterans General Hospital, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disabilities of the Arm, Shoulder, and Hand (DASH) score	30-item disability/symptom scale, scored 0 (no disability) to 100	averaged 2 years
Secondary	Radiographic examination	The union was defined as trabecular bridging across the fracture site	averaged 2 years