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Trial record 15 of 2694 for:    Arthroplasty

Patient Perceived Outcome After Total Wrist Arthroplasty With a New Total Wrist Arthroplasty Implant

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ClinicalTrials.gov Identifier: NCT02336009
Recruitment Status : Recruiting
First Posted : January 12, 2015
Last Update Posted : August 29, 2018
Sponsor:
Collaborator:
Örebro Läns Landsting
Information provided by (Responsible Party):
Anil Gupta, Örebro University, Sweden

Brief Summary:

Total wrist arthroplasty (TWA) surgery has developed gradually and can offer patients with rheumatoid arthritis/osteoarthritis reduced wrist pain with mainly preserved wrist range of movement. Each year 60-70 patients in Sweden are operated with a total wrist arthroplasty. Several implants are available on the market and they all have different pros and cons. One risk with a total wrist arthroplasty is loosening of the implant. If an implant is loose, revision of the implant to another TWA is sometimes possible, if not, a wrist fusion is the likely alternative. Revision rates five years after the index operation have improved, however, they cannot yet compare with the results after a total hip arthroplasty. A newly designed TWA has been developed by the department of Hand Surgery, Örebro university Hospital, Örebro, Sweden, in cooperation with Trimed Inc. The newly developed TWA offers theoretical advantages and has been biomechanically tested at the Mayo clinic.

This is a pilot study where patients operated with the TWA will be assessed pre and postoperatively according to study protocol in order to evaluate outcome after TWA radiologically, clinically and regarding patient perceived outcome measures.


Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Osteoarthritis Device: total wrist arthroplasty, Trimed Phase 2 Phase 3

Detailed Description:

Method: Patients will be studied preoperatively and after 1, 2, 5, and 10 years with respect to changes of the following outcome measures.

  1. Patient related outcome measures: DASH=Disabilities of Arm Shoulder and Hand, COPM=Canadian Occupational Performance Measure, PRWE=Patient Related Wrist Evaluation.
  2. Wrist range of motion: dorsal/volar flexion, ulnar/radial deviation, pronation/supination. Hand grip strength, pinch grip, key pinch.
  3. Wrist pain. VAS-pain scores (Visual analog score) at rest and in activity.
  4. X-ray findings. Implant survival will be studied with Kaplan-Meyer graphs.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical, Radiological and Patient Perceived Outcome After Total Wrist Arthroplasty With a New Total Wrist Arthroplasty Implant
Study Start Date : October 2014
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Arthritis

Arm Intervention/treatment
Experimental: total wrist arthroplasty, Trimed
This is a pilot study where all patients will be operated with the Trimed total wrist arthroplasty.
Device: total wrist arthroplasty, Trimed
A new total wrist arthroplasty design. A pilot study.




Primary Outcome Measures :
  1. revision rate [ Time Frame: changes in revision rates up to 10 years postoperatively ]
    The frequency of TWA implants revised up to 10 years after the index operation


Secondary Outcome Measures :
  1. changes in patient related outcome measures (PROM) [ Time Frame: 1, 2, 5, and 10 years postoperatively ]
    Assessed as DASH=Disabilities of Arm Shoulder and Hand, COPM=Canadian Occupational Performance Measure, PRWE=Patient Related Wrist Evaluation preoperatively and after 1, 2, 5, and 10 years postoperatively

  2. Changes in Range of Motion (ROM [ Time Frame: 1, 2, 5, and 10 years postoperatively ]
    flexion, extension, radial and ulnar deviation, pronation, supination. Hand grip strength, pinch grip, lateral grip, and radiographic loosening, VAS-pain scores.



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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Painful wrist arthritis
  • Wrightington X-ray grade 2-4.

Exclusion Criteria:

  • Infection
  • Substance abuse
  • Mental illness.

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): NCT02336009


Contacts
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Contact: Kurt Pettersson, MD, PhD 0046196025190 kurt.pettersson@orebroll.se
Contact: Marcus Sagerfors, MD 0046196025507 marcus.sagerfors@orebroll.se

Locations
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Sweden
Department of Hand Surgery Recruiting
Orebro, Sweden, 70185
Contact: Kurt Pettersson, MD, PhD    0046196025190    kurt.pettersson@orebroll.se   
Contact: Marcus Sagerfors, MD    0046196025507    marcus.sagerfors@orebroll.se   
Sponsors and Collaborators
Örebro University, Sweden
Örebro Läns Landsting
Investigators
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Principal Investigator: Kurt Pettersson, MD, PhD Orebro County Council, Orebro University

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Responsible Party: Anil Gupta, dr Anil Gupta, MD, FRCA, PhD, Örebro University, Sweden
ClinicalTrials.gov Identifier: NCT02336009     History of Changes
Other Study ID Numbers: Orebro Lans landsting 01-14
First Posted: January 12, 2015    Key Record Dates
Last Update Posted: August 29, 2018
Last Verified: August 2018
Keywords provided by Anil Gupta, Örebro University, Sweden:
wrist arthritis
total wrist arthroplasty
Additional relevant MeSH terms:
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Arthritis
Joint Diseases
Musculoskeletal Diseases