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The Use of Proximal Carpal Row Versus Iliac Crest as Bone Graft in Total Wrist Fusion (PROOF II)

Primary Purpose

Wrist Arthritis, Fusion; Joint

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
PRC
TWA
Sponsored by
Töölö Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Wrist Arthritis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age 18 - 75
  • Symptom duration > 3 months
  • American Society of Anaesthesiologists physical status (ASA) I-III
  • Fluent in written and spoken Finnish

Exclusion Criteria:

  • Age <18 or >75 years
  • Rheumatoid arthritis
  • Heavy smoking (> 20 cigarettes per day)
  • Condition or medication affecting bony healing (eg diabetes mellitus with poor glycemic control, malnutrition, use of per oral corticosteroids)
  • Ulnar variance > 1 mm
  • Wrist pain treatable with partial wrist fusion
  • Previous partial wrist fusion
  • Alcohol or drug abuse
  • Neurological condition affecting upper limb function
  • Less than 6 months after another operation of the same upper limb

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    PRC

    TWA

    Arm Description

    Total wrist arthrodesis with PRC and dorsal plate

    Total wrist arthrodesis with dorsal plate

    Outcomes

    Primary Outcome Measures

    Fusion rate (percent)

    Secondary Outcome Measures

    Pain (Visual Analogue Scale)
    The VAS is derived by health care professional question of pain in scale 0 to 100 mm (0 mm =no pain, 100 mm =worst possible pain)
    Patient-Rated Wrist Evaluation (PRWE)
    The PRWE comprises 15 questions to measure wrist pain and disability in daily activities. In PRWE patients rate wrist pain and disability from 0 to 10 and it consists two subscales: Pain and Function (0=best possible outcome, 10=worst possible outcome)
    Quick-Disabilities of the Arm, Shoulder and Hand (QuickDASH)
    The QuickDASH is self-reported questionnaire and shortened version of DASH outcome measure to measure physical function and symptoms in people with any or multiple musculoskeletal disorders of the upper limb in 11 dimensions in 1-5 scale (1=best possible outcome, 5=worst possible outcome)
    Global improvement
    Global rating to treatment effect will be evaluated by question: "How would you rate the function of your hand compared to the situation before the treatment?". The options are in 5-step Likert scale from (-2) Much worse to (+2) Much better
    Grip strength
    Grip strength is measured with a dynamometer in kg as the mean of three measurements. It will be numbered in kg and percentage of the unaffected side
    Operative time
    Operative time is measured in minutes for time in the operation theatre and time used for surgery
    Complications
    Incidence of complications (i.e. non-union, fracture, re-operation, infection, hematoma, iatrogenic tendon/nerve/arterial injury, complex regional pain syndrome) is recorded and compared between study groups.

    Full Information

    First Posted
    May 21, 2020
    Last Updated
    March 29, 2021
    Sponsor
    Töölö Hospital
    Collaborators
    Turku University Hospital, Kymenlaakso Central Hospital Kotka Finland
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04403958
    Brief Title
    The Use of Proximal Carpal Row Versus Iliac Crest as Bone Graft in Total Wrist Fusion
    Acronym
    PROOF II
    Official Title
    The Use of Proximal Carpal Row Versus Iliac Crest Bone Graft in Total Wrist Fusion - a Randomized Controlled Multicenter Trial Comparing Two Operative Techniques (PROOF II - Trial)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2021
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 1, 2021 (Anticipated)
    Primary Completion Date
    December 31, 2023 (Anticipated)
    Study Completion Date
    December 31, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Töölö Hospital
    Collaborators
    Turku University Hospital, Kymenlaakso Central Hospital Kotka Finland

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Study purpose is to compare the outcome after total wrist arthrodesis (TWA) with proximal carpal row (Proximal Row Carpectomy = PRC) as bone graft versus iliac crest cancellous bone graft. Patients with radiologically and clinically confirmed advanced osteoarthritis are randomized (1:1 computer generated sequence with random block size) to two parallel groups and will undergo either total wrist arthrodesis with PRC or TWA with iliac crest bone grafting. Baseline data is collected preoperatively and is a follow-up visits at every 6 weeks after the surgery is arranged until the wrist is fused. The primary end-point is 6 months and the primary outcome is fusion rate.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Wrist Arthritis, Fusion; Joint

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    84 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    PRC
    Arm Type
    Experimental
    Arm Description
    Total wrist arthrodesis with PRC and dorsal plate
    Arm Title
    TWA
    Arm Type
    Active Comparator
    Arm Description
    Total wrist arthrodesis with dorsal plate
    Intervention Type
    Procedure
    Intervention Name(s)
    PRC
    Intervention Description
    Total wrist arthrodesis with dorsal plate using proximal row of the wrist as bone graft
    Intervention Type
    Procedure
    Intervention Name(s)
    TWA
    Intervention Description
    Total wrist arthrodesis with dorsal plate using iliac crest as bone graft
    Primary Outcome Measure Information:
    Title
    Fusion rate (percent)
    Time Frame
    6 months
    Secondary Outcome Measure Information:
    Title
    Pain (Visual Analogue Scale)
    Description
    The VAS is derived by health care professional question of pain in scale 0 to 100 mm (0 mm =no pain, 100 mm =worst possible pain)
    Time Frame
    6 months
    Title
    Patient-Rated Wrist Evaluation (PRWE)
    Description
    The PRWE comprises 15 questions to measure wrist pain and disability in daily activities. In PRWE patients rate wrist pain and disability from 0 to 10 and it consists two subscales: Pain and Function (0=best possible outcome, 10=worst possible outcome)
    Time Frame
    6 months
    Title
    Quick-Disabilities of the Arm, Shoulder and Hand (QuickDASH)
    Description
    The QuickDASH is self-reported questionnaire and shortened version of DASH outcome measure to measure physical function and symptoms in people with any or multiple musculoskeletal disorders of the upper limb in 11 dimensions in 1-5 scale (1=best possible outcome, 5=worst possible outcome)
    Time Frame
    6 months
    Title
    Global improvement
    Description
    Global rating to treatment effect will be evaluated by question: "How would you rate the function of your hand compared to the situation before the treatment?". The options are in 5-step Likert scale from (-2) Much worse to (+2) Much better
    Time Frame
    6 months
    Title
    Grip strength
    Description
    Grip strength is measured with a dynamometer in kg as the mean of three measurements. It will be numbered in kg and percentage of the unaffected side
    Time Frame
    6 months
    Title
    Operative time
    Description
    Operative time is measured in minutes for time in the operation theatre and time used for surgery
    Time Frame
    Perioperative
    Title
    Complications
    Description
    Incidence of complications (i.e. non-union, fracture, re-operation, infection, hematoma, iatrogenic tendon/nerve/arterial injury, complex regional pain syndrome) is recorded and compared between study groups.
    Time Frame
    12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age 18 - 75 Symptom duration > 3 months American Society of Anaesthesiologists physical status (ASA) I-III Fluent in written and spoken Finnish Exclusion Criteria: Age <18 or >75 years Rheumatoid arthritis Heavy smoking (> 20 cigarettes per day) Condition or medication affecting bony healing (eg diabetes mellitus with poor glycemic control, malnutrition, use of per oral corticosteroids) Ulnar variance > 1 mm Wrist pain treatable with partial wrist fusion Previous partial wrist fusion Alcohol or drug abuse Neurological condition affecting upper limb function Less than 6 months after another operation of the same upper limb
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Samuli Aspinen, M.D., Ph.D.
    Phone
    +358406360546
    Email
    samuli.aspinen@hus.fi
    First Name & Middle Initial & Last Name or Official Title & Degree
    Jorma Ryhänen, adj. prof.
    Email
    jorma.ryhanen@hus.fi
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Samuli Aspinen, M.D., Ph.D.
    Organizational Affiliation
    HUS Töölö Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    The Use of Proximal Carpal Row Versus Iliac Crest as Bone Graft in Total Wrist Fusion

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