2.4 mm Variable Angle LCP Two-Column Volar Distal Radius

NCT01103297 | Completed Phase 4

• 1 other identifier: VALCPDR
• Study Type: interventional
• Target: 74
• Locations: 3 countries
• Sites: 6

Brief Summary

The purpose of this study is to is to evaluate the postoperative loss of reduction rate in patients with distal radius fractures treated using the 2.4 mm Variable Angle LCP Two-Column Volar Distal Radius Plate ®.

Conditions

Distal Radius Fractures

Keywords

Distal radius fracture; Double row plate; Volar approach; DVR plate; Postoperative complications [MeSH]

Outcome Measures

Primary Outcomes (1)

• Loss of reduction

  Loss of reduction will be defined as the change in measurement\* determined to 0.5 mm or 1 degree of accuracy: \*Any change in angles, length or secondary fragment displacement (ie, radial height (length), radial inclination, ulnar variance, gap, step-off, palmar tilt (inclination) / dorsal tilt, scapholunate angle, teardrop angle, and the AP distance).

  over 1 year

Secondary Outcomes (14)

• Rate of fracture fixation complications

  Baseline

• Wrist function

  12 weeks

• Grip strength

  12 weeks

• Wrist pain and disability in functional activities

  Baseline

• Quality of Life

  Baseline

Study Arms (1)

Variable Angle Distal Radius Plate

OTHER

Device: Variable Angle Distal Radius Plate ® (Surgery)

Interventions

Variable Angle Distal Radius Plate ® (Surgery) DEVICE

Fracture reduction with distal radius plate

Also known as: 2.4 Variable Angle LCP Two-Column Volar Distal Radius Plate®

Variable Angle Distal Radius Plate

Eligibility Criteria

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

You may qualify if:

• Patients aged ≥ 18 years
• Patients with closed, partial or complete articular distal radius fractures classified as: AO 23 B3 and AO 23 C1, C2, C3 confirmed by CT scan
• Definitive primary fracture treatment with a VA LCP DR
• The patient is willing and able to participate in the study follow-up examinations according to the protocol
• The patient is able to understand and read the local language at an elementary level
• The patient or his/her legal guardian is willing and able to give his informed consent to participate in the study
• Woman must be one of the following:
• Postmenopausal defined as amenorrhea for at least 6 months before screening and a serum follicle stimulating hormone (FSH) level consistent with postmenopausal status
• Surgically sterile, (have had a hysterectomy or bilateral oophorectomy, tubal ligation, or otherwise be incapable of pregnancy)
• Abstinent (at the discretion of the investigator) or,
• If sexually active, be practicing an effective method of birth control such as hormonal prescription oral contraceptives, progesterone implants or injections, intrauterine device (IUD), a double-barrier method such as condoms, diaphragms or cervical caps with spermicidal foam, cream or gel, or male partner with a vasectomy.
• Women of childbearing potential must have a negative serum β-human chorionic gonadotropin (β-hCG) pregnancy test, or a negative urine pregnancy test at screening.

You may not qualify if:

• Previous ipsilateral distal radius fracture
• Other fractures of the ipsilateral side (except ulna)
• Pathologic fracture due to malignancy
• The patient suffers from a polytrauma
• The patient is affected by drug or alcohol abuse
• The patient suffers from active malignancy
• Neurological and psychiatric disorders
• The patient has participated in any other device or drug related clinical trial within the previous month
• The patient is a prisoner
• Breast feeding woman

Sponsors & Collaborators

• AO Clinical Investigation and Publishing Documentation: lead

Study Sites (6)

Unfallkrankenhaus Graz

Graz, 8020, Austria

Location

Charite Berlin

Berlin, Germany

Location

Universitätssklinikum Münster

Münster, 48149, Germany

Location

Universitätsspital Basel

Basel, Basel, 4056, Switzerland

Location

Luzerner Kantonsspital

Lucerne, Canton of Lucerne, 6000, Switzerland

Location

Spital Zollikerberg

Zurich, 8008, Switzerland

Location

MeSH Terms

Conditions

Wrist Fractures

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

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

Study Officials

• Jesse B Jupiter, MD

  Massachusetts General Hospital, Orthopaedic Surgery, Yawkey Center, Suite 2100, 55 Fruit Street, Boston, MA 02114, USA

  PRINCIPAL INVESTIGATOR

• Andreas Schierz, MD

  Spital Zollikerberg, Unfallchirurgie, Trichtenhauserstrasse 20, CH-8125 Zollikerberg, Switzerland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2010
• First Posted: April 14, 2010
• Study Start: June 1, 2010
• Primary Completion: February 1, 2014
• Study Completion: May 1, 2014
• Last Updated: September 19, 2014

Record last verified: 2014-09

Locations

CH (3); AU (1); DE (2)