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Distal Radius FracturesPhase 4VALCP2010NCT01103297

2.4 mm Variable Angle LCP Two-Column Volar Distal Radius

A Phase 4 study testing Variable Angle Distal Radius Plate ® (Surgery) in people with Distal Radius Fractures, run by AO Clinical Investigation and Publishing Documentation at 6 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 ®. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Distal Radius Fractures
What is being tested?
Variable Angle Distal Radius Plate ® (Surgery)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
74 participants
Where
6 sitesin 3 countries
Study dates
Jun 2010to May 2014
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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.

Who cannot join

  • 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
Show all 10Show fewer
  • 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

Trial locations and contacts

6 sites in 3 countries.

6 sites in 3 countries

Switzerland3 sites

  • Universitätsspital Basel

    Basel, Basel, 4056

  • Luzerner Kantonsspital

    Lucerne, Canton of Lucerne, 6000

  • Spital Zollikerberg

    Zurich, 8008

Other trials in Switzerland

Germany2 sites

  • Charite Berlin

    Berlin

  • Universitätssklinikum Münster

    Münster, 48149

Other trials in Germany

Austria1 site

  • Unfallkrankenhaus Graz

    Graz, 8020

Other trials in Austria

About this study

Official title: A Prospective Multicenter Case-series of Patients Treated With the 2.4 mm Variable Angle LCP Two-Column Volar Distal Radius Plate ®

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 ®.

Read the 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.

Being tested
Variable Angle Distal Radius Plate ® (Surgery)
Keywords
Distal radius fracture, Double row plate, Volar approach, DVR plate, Postoperative complications [MeSH]
Medical subject headings
Wrist Fractures

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Variable Angle Distal Radius Plate ® (Surgery)Device

    Also called 2.4 Variable Angle LCP Two-Column Volar Distal Radius Plate®

    Fracture reduction with distal radius plate

Study groups in NCT01103297
Study groupRoleWhat they receive
Variable Angle Distal Radius PlateOtherNot described
Receives: Device: Variable Angle Distal Radius Plate ® (Surgery)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: over 1 year

Secondary outcomes (14)

  1. Rate of fracture fixation complications

    Measured: Baseline

  2. Wrist function

    Bilateral Range of motion (ROM)

    Measured: 12 weeks

  3. Grip strength

    With Jamar dynamometer

    Measured: 12 weeks

  4. Wrist pain and disability in functional activities

    Patient self-assessment of wrist function questionnaire (PRWE)

    Measured: Baseline

  5. Quality of Life

    Health-related quality of life (EQ5D)

    Measured: Baseline

  6. Implantation and system feedback

    Measured: Baseline

  7. Rate of fracture fixation complications

    Measured: 12 weeks

  8. Rate of fracture fixation complications

    Measured: 1 year

  9. Wrist function

    Bilateral Range of motion (ROM)

    Measured: 1 year

  10. Grip strength

    With Jamar dynamometer

    Measured: 1 year

  11. Wrist pain and disability in functional activities

    Patient self-assessment of wrist function questionnaire (PRWE)

    Measured: 12 weeks

  12. Wrist pain and disability in functional activities

    Patient self-assessment of wrist function questionnaire (PRWE)

    Measured: 1 year

  13. Quality of Life

    Health-related quality of life (EQ5D)

    Measured: 12 weeks

  14. Quality of Life

    Health-related quality of life (EQ5D)

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Apr 2010 (estimated)
  2. Study startJun 2010
  3. Primary completionFeb 2014
  4. Study completionMay 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
74 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01103297
Sponsor's protocol ID
VALCPDR
Acronym
VALCP2010
Status last verified
Sep 2014
First submitted
25 Mar 2010
Last updated
19 Sep 2014
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Variable Angle Distal Radius Plate ® (Surgery) in people with Distal Radius Fractures, run by AO Clinical Investigation and Publishing Documentation at 6 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Switzerland, Germany, Austria. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Loss of reduction (time frame: over 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01103297.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2014.

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