percutaneous surgery for scaphoid nonunion

JRCT ID: jRCTs052180093

Registered date:05/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Scaphoid nonunion
• Date of first enrollment: 10/07/2015
• Target sample size: 10
• Study type: Interventional

Intervention(s)

Therapeutic intervention study
Confirmatory study
No control
No allocation
Unblinded
Assessor- blinded

Methods
Inclusion criteria;
Herbert classification C and D1.
Exclusion criteria; Herbert classification D2.
Operative procedure;
General anesthesia or regional anesthesia
1.Insert a guidewire and a second derotaion wire percutaneously.
2.Pass a cannulated drill over the guidewire to the distal end of the cystic lesion.
3.Remove the guidewire.
4.Refresh the inner surface of cystic lesion using a small curette inserted through the distal screw insertion hole.
5.Harvest illiac bone graft using a bone biopsy needle.
6.Insert bone graft into the cystic lesion through the drill hole.
7.Reinsert the removed guidewire into the previously drilled hole.
8.Insert a fully threaded headless screw.
9.Thumb spica cast for 4~6 weeks followed by splinting

Outcome(s)

Primary Outcome

Primary outcome; bone union three months after the surgery.
Measurement outcomes; wrist range of motion (ROM), grip strength, visual analogue scale (VAS) for pain, Mayo wrist score, quick DASH. Scapho-lunate angle and radio-lunate angle in radiography.
Three months after the surgery, bone union is assessed using CT.
Measurement schedule; preoperation, 3 months, 1 year, 2 years after the surgery.

• Secondary Outcome: Secondary outcomes; wrist ROM, grip strength, pain, ADL

Key inclusion & exclusion criteria

• Age minimum: >= 16age old
• Age maximum: Not applicable
• Gender: Both
• Include criteria: Scaphoid nonunions; A radiolucent line or a cystic formation are confirmed using radiography or computed tomography over 6 weeks after the injury.
• Exclude criteria: patients under 15 years old

Related Information

• Primary Sponsor: Ohta Souichi