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Comparison of ARPE Prosthesis With the Literature

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ClinicalTrials.gov Identifier: NCT01904019
Recruitment Status : Active, not recruiting
First Posted : July 19, 2013
Last Update Posted : July 7, 2020
Sponsor:
Collaborator:
Biomet Belgium BVBA
Information provided by (Responsible Party):
Zimmer Biomet

Brief Summary:
Comparison of functional outcome at 3 years after trapezio-metacarpal arthroplasty with trapeziectomy and trapeziectomy with ligament reconstruction and tendon interposition.

Condition or disease
Arthritis

Detailed Description:

The primary objective is to compare functional outcome at 3 years after trapezio-metarcarpal arthroplasty with trapeziectomy and trapeziectomy with ligament reconstruction and tendon interposition. Literature values obtained by a recently published meta analysis1 will be used.

Secondary objectives are:

  • to compare functional outcome at 1 and at 5 years after trapezio-metarcarpal arthroplasty with trapeziectomy and trapeziectomy with ligament reconstruction and tendon interposition
  • to determine pre- and postop HR QOL
  • Incidence of RLL at each follow up time point. Literature values from the same meta analysis1 will be used.

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Trapezia-metacarpal Arthroplasty: Comparison of ARPE Prosthesis With the Literature
Study Start Date : April 2013
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : December 2020



Primary Outcome Measures :
  1. Functional outcome [ Time Frame: 3 years follow-up ]
    Functional outcome: hand function, strength (grip, key pinch & tip pinch)


Secondary Outcome Measures :
  1. pain evaluation [ Time Frame: 5 years follow-up ]
    Pain level collected on a horizontal line, rated from 0 (no pain) to 100 (very severe pain)

  2. hand function [ Time Frame: 5 years follow-up ]
    - functional outcomes at 1 and 5 years follow up after trapezio-metacarpal arthroplasty / trapeziectomy and trapeziectomy with LRTI.

  3. Motion [ Time Frame: 5 years follow-up ]
    - ROM (palmar and radial abduction)at 1, 3 & 5 years follow-up

  4. Quality of life determined by the EQ-5D score [ Time Frame: 5 years follow-up ]

    EQ-5D is a standardized instrument for measuring health status. It is made up for two components.

    The description part: health status is measured in five dimensions (5D); mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Mobility dimension asks about the person's walking ability. Self-care dimension asks about the ability to wash or dress by oneself. Usual activities dimension measures performance in "work, study, housework, family or leisure activities". In pain/discomfort dimension, it asks how much pain or discomfort they have. In anxiety/depression dimension, it asks how anxious or depressed they are.

    Visual analogue scale: The patient marks his health status on the day of the interview on a 20 cm vertical scale with end points of 0 and 100. The bottom rate (0) corresponds to " the worst health you can imagine", and the highest rate (100) corresponds to "the best health you can imagine".


  5. Radiographic assessment [ Time Frame: 5 years follow-up ]
    - Incidence of Radiolucency lines at 1, 3 & 5 years follow-up

  6. adverse event [ Time Frame: as requested ]
    - frequency of postoperative adverse events



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
patients with trapezio-metacarpal arthritis Eaton Stage of trapezio-metacarpal arthritis : Stage II - IV
Criteria

Inclusion Criteria:

  • patients with trapezio-metacarpal arthritis Eaton Stage of trapezio-metacarpal arthritis : Stage II - IV
  • willing to return for follow up evaluation.

Exclusion Criteria:

  • local or systemic infections
  • severe muscular, neurological or vascular deficiencies of the extremity involved
  • bone destruction or poor bone to affect implant stability
  • allergy to any of the components of the implant

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01904019


Locations
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Belgium
SPM Deurne
Deurne, Belgium, 2100
Sponsors and Collaborators
Zimmer Biomet
Biomet Belgium BVBA
Investigators
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Principal Investigator: Frederik VERSTREKEN, PhD SPM Deurne
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Responsible Party: Zimmer Biomet
ClinicalTrials.gov Identifier: NCT01904019    
Other Study ID Numbers: ORTHO.CR.E16
First Posted: July 19, 2013    Key Record Dates
Last Update Posted: July 7, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Zimmer Biomet:
arthroplasty
trapezio-metacarpial
Additional relevant MeSH terms:
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Arthritis
Joint Diseases
Musculoskeletal Diseases