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Trapeziometacarpal Prosthesis vs. Resection-Interposition Arthroplasty

Primary Purpose

Arthropathy of Hand

Status
Active
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Epping resection arthroplasty
CMC I prosthesis
Sponsored by
Medical University of Graz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Arthropathy of Hand

Eligibility Criteria

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

Inclusion Criteria:

  • symptomatic rhizarthrosis grade 2 and 3 according to Eaton's classification,
  • failed conservative treatment prior to surgery,
  • written informed consent to the study.

Exclusion Criteria:

  • scaphotrapezotrapezoidal (STT) arthrosis,
  • former CMC joint surgery,
  • patients under custodianship.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Epping resection arthroplasty

    CMC I prosthesis group

    Arm Description

    During the Epping resection-suspension arthroplasty the trapeziectomy is performed, the flexor carpi radialis tendon is divided into two parts and one of these is stripped and cut proximally. To prevent shortening of the first ray with following loss of strength, this tendon strip is pulled through a drill hole in the base of the 1st metacarpal from ulnar palmar to radial dorsal. The rest of the tendon strip is sutured to a roll replacing the os trapezium.

    During implantation of the prosthesis the CMC joint is opened and 3 mm of the metacarpal base as well as osteophytes are resected. Following the release of the trapezium the first metacarpal and the trapezium are prepared for the prosthesis by broaching and drilling. After the test-implants have shown satisfying joint tension and anatomic conditions, the HA coated stem and cup are pressfit inserted in the appropriate size followed by the modular head.

    Outcomes

    Primary Outcome Measures

    Functional outcome- Thumb opposition
    Measurement of thumb opposition (scale from 1 to 10) range according to Kapandji. A score of 0 indicates no opposition, a score of 10 indicates maximal opposition.
    Functional outcome - Thumb retropulsion
    Measurement of thumb retropulsion (scale from 1 to 3) range according to Kapandji
    Functional outcome - maximal palmar abduction
    measurement of the maximal palmar abduction using a goniometer.
    Functional outcome - maximal radial abduction
    measurement of the maximal radial abduction using a goniometer.
    Functional outcome - tip-to-tip force
    The tip-to-tip force (between thumb and index finger) was measured in Newton (N) using a handheld dynamometer (Cit Technics, Haren, Netherlands).

    Secondary Outcome Measures

    Full Information

    First Posted
    January 24, 2022
    Last Updated
    February 23, 2022
    Sponsor
    Medical University of Graz
    Collaborators
    Stryker Instruments
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05267964
    Brief Title
    Trapeziometacarpal Prosthesis vs. Resection-Interposition Arthroplasty
    Official Title
    Trapeziometacarpal Prosthesis vs. Resection-Interposition Arthroplasty A Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2022
    Overall Recruitment Status
    Active, not recruiting
    Study Start Date
    November 1, 2014 (Actual)
    Primary Completion Date
    November 30, 2019 (Actual)
    Study Completion Date
    April 1, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Medical University of Graz
    Collaborators
    Stryker Instruments

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Rhizarthrosis is a frequently occurring pathology leading to severe limitations in daily life due to pain and loss of function. Good clinical results have been reported for some carpometacarpal (CMC) joint prosthesis designs, but high failure rates due to loosening and dislocation must be considered. The study aim was to investigate a new, double mobility CMC-prosthesis design with special focus on (1) the functional outcome and (2) patient quality of life (QOL)
    Detailed Description
    The Epping resection-suspension arthroplasty procedure was described in 1983 to address the proximal migration of the first ray while providing pain free grip strength without any implants. It has shown rather good functional outcome and pain relief. A reduction in thumb opposition strength of 27% compared to the contralateral side and intermittent pain in physical activity is reported, however. Further, studies comparing trapeziectomy and trapeziectomy with tendon interposition recommend trapeziectomy due to the simple technique and comparable outcome. Endoprosthesis of the first carpometacarpal (CMC) joint represents a different treatment strategy aiming at an exact reconstruction of the joint geometry. Some studies report excellent functional outcome and pain relief. However, there are some prosthesis designs (cemented and uncemented) with high rates of loosening, luxation and poor subjective results. To address these issues, a prosthesis was designed combining a cylindric, double mobility cup and a hydroxyapatite covered stem and cup available in different sizes. The aim of this study was to compare this new prosthesis design to the Epping arthroplasty as the current standard in the investigator's institution regarding (1) the functional outcome with special focus on mobility and strength and (2) patient quality of life (QOL) and pain relief. Note: The registration of this trial on Clinicaltrials.gov was carried out retrospectively after primary completion of the study.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Arthropathy of Hand

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Masking Description
    Patients are radomized into two groups prior to the surgical intervention using the radomizing programm of the medical university of graz.
    Allocation
    Randomized
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Epping resection arthroplasty
    Arm Type
    Active Comparator
    Arm Description
    During the Epping resection-suspension arthroplasty the trapeziectomy is performed, the flexor carpi radialis tendon is divided into two parts and one of these is stripped and cut proximally. To prevent shortening of the first ray with following loss of strength, this tendon strip is pulled through a drill hole in the base of the 1st metacarpal from ulnar palmar to radial dorsal. The rest of the tendon strip is sutured to a roll replacing the os trapezium.
    Arm Title
    CMC I prosthesis group
    Arm Type
    Active Comparator
    Arm Description
    During implantation of the prosthesis the CMC joint is opened and 3 mm of the metacarpal base as well as osteophytes are resected. Following the release of the trapezium the first metacarpal and the trapezium are prepared for the prosthesis by broaching and drilling. After the test-implants have shown satisfying joint tension and anatomic conditions, the HA coated stem and cup are pressfit inserted in the appropriate size followed by the modular head.
    Intervention Type
    Procedure
    Intervention Name(s)
    Epping resection arthroplasty
    Intervention Description
    Follwing the described epping resection arthroplasty, The first ray was immobilized using an orthosis for four weeks postoperatively in both study groups followed by eight weeks of physical therapy.
    Intervention Type
    Procedure
    Intervention Name(s)
    CMC I prosthesis
    Intervention Description
    Follwing the described CMC I prosthesis procedure, The first ray was immobilized using an orthosis for four weeks postoperatively in both study groups followed by eight weeks of physical therapy.
    Primary Outcome Measure Information:
    Title
    Functional outcome- Thumb opposition
    Description
    Measurement of thumb opposition (scale from 1 to 10) range according to Kapandji. A score of 0 indicates no opposition, a score of 10 indicates maximal opposition.
    Time Frame
    twelve months postoperative
    Title
    Functional outcome - Thumb retropulsion
    Description
    Measurement of thumb retropulsion (scale from 1 to 3) range according to Kapandji
    Time Frame
    twelve months postoperative
    Title
    Functional outcome - maximal palmar abduction
    Description
    measurement of the maximal palmar abduction using a goniometer.
    Time Frame
    twelve months postoperative
    Title
    Functional outcome - maximal radial abduction
    Description
    measurement of the maximal radial abduction using a goniometer.
    Time Frame
    twelve months postoperative
    Title
    Functional outcome - tip-to-tip force
    Description
    The tip-to-tip force (between thumb and index finger) was measured in Newton (N) using a handheld dynamometer (Cit Technics, Haren, Netherlands).
    Time Frame
    twelve months postoperative

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: symptomatic rhizarthrosis grade 2 and 3 according to Eaton's classification, failed conservative treatment prior to surgery, written informed consent to the study. Exclusion Criteria: scaphotrapezotrapezoidal (STT) arthrosis, former CMC joint surgery, patients under custodianship.

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    IPD Sharing Plan Description
    IPD can be shared at reasonable request.

    Learn more about this trial

    Trapeziometacarpal Prosthesis vs. Resection-Interposition Arthroplasty

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