Minimally Invasive Closed Reduction and Internal Fixation With Screws for Distal Radius Fracture

NCT02784678 | Unknown DMC

• 1 other identifier: ShenyangMC_001
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to confirm that minimally invasive closed reduction and internal fixation with fully threaded headless cannulated compression screws for distal radius fracture repair has advantages over conventional open reduction internal fixation with titanium plates, providing superior fragment stability and allowing for early rehabilitation exercise of the wrist joint, which improves recovery of function. Also to show that minimally invasive closed reduction and internal fixation with fully threaded headless cannulated compression screws is the more suitable surgical method for repair of distal radius fracture.

Conditions

Distal Radius Fracture

Outcome Measures

Primary Outcomes (1)

• change of X-ray findings

  X-ray findings to evaluate fracture healing

  Baseline and week 3, week 6, week 12, week 24 after surgery

Secondary Outcomes (4)

• change of CT findings

  Baseline and week 3, week 6, week 12, week 24 after surgery

• change of patient-rated wrist evaluation score results

  week 3, week 6, week 12, week 24 after surgery

• change of healing of fracture

  week 3, week 6, week 12, week 24 after surgery

• change of Visual Analogue Scale(VAS) score

  week 3, week 6, week 12, week 24 after surgery

Study Arms (2)

closed reduction group

EXPERIMENTAL

Patients will be assigned to C-arm fluoroscopy-assisted minimally invasive closed reduction and internal fixation with fully threaded headless cannulated compression screws (experimental group).

Procedure: closed reduction group

open reduction group

EXPERIMENTAL

Patients will be assigned to open reduction (palmar and dorsal incisions) and internal fixation with titanium plate (control group).

Device: open reduction group

Interventions

closed reduction group PROCEDURE

Patients in the experimental group will undergo C-arm fluoroscopy-assisted minimally invasive closed reduction and internal fixation with fully threaded headless cannulated compression screws. In the experimental group, fractures will be reduced and internally fixed with fully threaded headless cannulated compression screws of appropriate lengths (Acutrak plus; Acumed Inc., Beaverton, OR, USA) under C-arm fluoroscopic guidance to restore the radial inclination and ulnar deviation of the distal radius.

Also known as: minimally invasive closed reduction and internal fixation

closed reduction group

open reduction group DEVICE

Patients in the control group will undergo open reduction and internal fixation with a titanium plate (Ningbo Cibei Medical Treatment Appliance Co., Ltd., Ningbo, China).

Also known as: open reduction and internal fixation

open reduction group

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 55 years or older, either sex
• A history of known trauma
• Presence of wrist joint pain and limitation of motion after trauma
• Fracture occurring 2.0-3.0 cm proximal to the articular surface, confirmed with imaging findings
• Unstable distal radius fracture
• Dorsal displacement of fracture fragment
• Fracture involving the wrist joint, but no more than two fracture fragments involving the wrist joint

You may not qualify if:

• Acute fracture of several other regions, including the ulnar styloid process
• Open fracture
• Mental disorder
• Occurrence of fracture more than 21 days before presentation
• Severe heart, lung, liver, or kidney function disorder
• Severe local infection after fracture
• Refusal to sign informed consent form
• Poor compliance, or upon the request of the sponsor for safety reasons
• If participation in the trial would be a potential hazard to patient's health

Sponsors & Collaborators

• Shenyang Medical College: lead

MeSH Terms

Conditions

Wrist Fractures

Interventions

Fracture Fixation, Internal; Open Fracture Reduction

Condition Hierarchy (Ancestors)

Wrist Injuries; Arm Injuries; Wounds and Injuries; Fractures, Bone

Intervention Hierarchy (Ancestors)

Fracture Fixation; Orthopedic Procedures; Therapeutics; Surgical Procedures, Operative

Study Officials

• Zhi Li, Master

  Department of Orthopedic Surgery, Central Hospital Affiliated to Shenyang Medical College, Shenyang, Liaoning Province, China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhi Li, Master

CONTACT

8618002479373; zhili_chsmc@sina.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: May 5, 2016
• First Posted: May 27, 2016
• Study Start: June 1, 2016
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2018
• Last Updated: May 27, 2016

Record last verified: 2016-05