2.4 mm Variable Angle LCP Two-Column Volar Distal Radius - Full Text View

Sponsor:	AO Clinical Investigation and Documentation
Information provided by (Responsible Party):	AO Clinical Investigation and Documentation
ClinicalTrials.gov Identifier:	NCT01103297

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 IV

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:

MedlinePlus related topics: Fractures

U.S. FDA Resources

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)

Estimated Enrollment:	74
Study Start Date:	June 2010
Estimated Study Completion Date:	November 2012
Estimated Primary Completion Date:	August 2012 (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

Contacts and Locations

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

Contacts

Contact: Marta T Marent-Huber	+41442002466	marta.marent@aofoundation.org
Contact: Andreas Faeh	+41442002467	andreas.feah@aofoundation.org

Locations

United States, Massachusetts
Jesse B Jupiter	Not yet recruiting
Boston, Massachusetts, United States, 02114
Principal Investigator: Jesse B Jupiter, MD
Switzerland
Spital Zollikerberg	Recruiting
Zürich, Switzerland, 8008
Contact: Andreas Schierz, MD +41 44 397 2295 andreas.schierz@spitalzollikerberg.ch

Sponsors and Collaborators

AO Clinical Investigation and Documentation

Investigators

Principal Investigator:	Douglas A Campbell, MD	The General Infirmary at Leeds, Great George St., West Yorkshire, Leeds, LS1 3EX, Great Britain
Principal Investigator:	Rupert Eckersley, MD	Chelsea and Westminster Hospital, 369 Fulham Road, London, SWID 9NH, Great Britain
Principal Investigator:	Thomas J Fischer, MD	Indiana Hand Center, 8501 Harcourt Road, P.O. Box 80434, Indianapolis, IN 46280-0434, USA
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:	October 7, 2011
Health Authority:	Switzerland: Ethikkommission; United Kingdom: Research Ethics Committee; United States: Institutional Review Board

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:

Fractures, Bone
Radius Fractures
Wounds and Injuries
Forearm Injuries
Arm Injuries

ClinicalTrials.gov processed this record on February 09, 2012