2.4 mm Variable Angle LCP Two-Column Volar Distal Radius (VALCP2010)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AO Clinical Investigation and Documentation
ClinicalTrials.gov Identifier:
NCT01103297
First received: March 25, 2010
Last updated: September 18, 2014
Last verified: September 2014
  Purpose

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 ®.


Condition Intervention Phase
Distal Radius Fractures
Device: Variable Angle Distal Radius Plate ® (Surgery)
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective Multicenter Case-series of Patients Treated With the 2.4 mm Variable Angle LCP Two-Column Volar Distal Radius Plate ®

Resource links provided by NLM:


Further study details as provided by AO Clinical Investigation and Documentation:

Primary Outcome Measures:
  • Loss of reduction [ Time Frame: over 1 year ] [ Designated as safety issue: No ]

    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).



Secondary Outcome Measures:
  • Rate of fracture fixation complications [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Wrist function [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Bilateral Range of motion (ROM)

  • Grip strength [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    With Jamar dynamometer

  • Wrist pain and disability in functional activities [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Patient self-assessment of wrist function questionnaire (PRWE)

  • Quality of Life [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Health-related quality of life (EQ5D)

  • Implantation and system feedback [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Rate of fracture fixation complications [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Rate of fracture fixation complications [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Wrist function [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Bilateral Range of motion (ROM)

  • Grip strength [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    With Jamar dynamometer

  • Wrist pain and disability in functional activities [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Patient self-assessment of wrist function questionnaire (PRWE)

  • Wrist pain and disability in functional activities [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Patient self-assessment of wrist function questionnaire (PRWE)

  • Quality of Life [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Health-related quality of life (EQ5D)

  • Quality of Life [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Health-related quality of life (EQ5D)


Enrollment: 74
Study Start Date: June 2010
Study Completion Date: May 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Variable Angle Distal Radius Plate Device: Variable Angle Distal Radius Plate ® (Surgery)
Fracture reduction with distal radius plate
Other Name: 2.4 Variable Angle LCP Two-Column Volar Distal Radius Plate®

Detailed Description:

The treatment of choice for distal radius fractures is anatomic reduction with stable fixation. This is commonly achieved via open reduction and internal fixation with angle-stable designed locking plates using either a volar or dorsal approach. Frequent complications of tendinitis are associated with the latter approach. Palmar application of angle-stable plates reduces this problem of extensor tendon irritation; however a high incidence of fracture collapse has been documented. Currently, there are no existing locking plates that provide sufficient stability particularly for complex fractures. Insufficient fragment fixation can result in loss of reduction due to interfragmentary movement and lead to mal- or nonunion.

The Variable Angle LCP Two-Column Volar DR plate (VA LCP DR) is a novel development of the LCP Distal Radius Plate System, which is designed to treat a wide variety of distal radius fracture patterns. Because of its design (ie, low plate and screw profile, polished surface, rounded edges, various locking options), not only can the potential for tendon adhesions and soft tissue irritation be minimized, the plate can address fragments individually for each fracture type. Thus, the versatility of VA LCP facilitates the reduction and stabilization of even the most complex fractures, including those in osteoporotic bone.

This prospective case-series will evaluate the performance of the new VA LCP DR plate in the treatment of complex articular fractures of the distal radius. The primary objective of this study involves the documentation of postoperative loss of reduction; functional outcomes, quality of life and rate of complications associated with fracture fixation will also be assessed as part of the secondary study aims.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01103297

Locations
Austria
Unfallkrankenhaus Graz
Graz, Austria, 8020
Germany
Charite Berlin
Berlin, Germany
Universitätssklinikum Münster
Münster, Germany, 48149
Switzerland
Universitätsspital Basel
Basel, Switzerland, 4056
Luzerner Kantonsspital
Luzern, Switzerland, 6000
Spital Zollikerberg
Zürich, Switzerland, 8008
Sponsors and Collaborators
AO Clinical Investigation and Documentation
Investigators
Principal Investigator: 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
  More Information

No publications provided

Responsible Party: AO Clinical Investigation and Documentation
ClinicalTrials.gov Identifier: NCT01103297     History of Changes
Other Study ID Numbers: VALCPDR
Study First Received: March 25, 2010
Last Updated: September 18, 2014
Health Authority: Switzerland: Ethikkommission
Germany: Federal Office for Radiation Protection
Germany: Federal Institute for Drugs and Medical Devices
Austria: Federal Office for Safety in Health Care

Keywords provided by AO Clinical Investigation and Documentation:
Distal radius fracture
Double row plate
Volar approach
DVR plate
Postoperative complications [MeSH]

Additional relevant MeSH terms:
Radius Fractures
Forearm Injuries
Arm Injuries
Wounds and Injuries
Fractures, Bone

ClinicalTrials.gov processed this record on September 22, 2014