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

Primary Purpose

Rheumatoid Arthritis, Osteoarthritis

Status
Unknown status
Phase
Phase 2
Locations
Sweden
Study Type
Interventional
Intervention
total wrist arthroplasty, Trimed
Sponsored by
Örebro University, Sweden
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring wrist arthritis, total wrist arthroplasty

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • Infection
  • Substance abuse
  • Mental illness.

Sites / Locations

  • Department of Hand SurgeryRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

total wrist arthroplasty, Trimed

Arm Description

This is a pilot study where all patients will be operated with the Trimed total wrist arthroplasty.

Outcomes

Primary Outcome Measures

revision rate
The frequency of TWA implants revised up to 10 years after the index operation

Secondary Outcome Measures

changes in patient related outcome measures (PROM)
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
Changes in Range of Motion (ROM
flexion, extension, radial and ulnar deviation, pronation, supination. Hand grip strength, pinch grip, lateral grip, and radiographic loosening, VAS-pain scores.

Full Information

First Posted
November 24, 2014
Last Updated
August 28, 2018
Sponsor
Örebro University, Sweden
Collaborators
Örebro Läns Landsting
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1. Study Identification

Unique Protocol Identification Number
NCT02336009
Brief Title
Patient Perceived Outcome After Total Wrist Arthroplasty With a New Total Wrist Arthroplasty Implant
Official Title
Clinical, Radiological and Patient Perceived Outcome After Total Wrist Arthroplasty With a New Total Wrist Arthroplasty Implant
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Unknown status
Study Start Date
October 2014 (undefined)
Primary Completion Date
October 2019 (Anticipated)
Study Completion Date
December 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Örebro University, Sweden
Collaborators
Örebro Läns Landsting

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis, Osteoarthritis
Keywords
wrist arthritis, total wrist arthroplasty

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
total wrist arthroplasty, Trimed
Arm Type
Experimental
Arm Description
This is a pilot study where all patients will be operated with the Trimed total wrist arthroplasty.
Intervention Type
Device
Intervention Name(s)
total wrist arthroplasty, Trimed
Intervention Description
A new total wrist arthroplasty design. A pilot study.
Primary Outcome Measure Information:
Title
revision rate
Description
The frequency of TWA implants revised up to 10 years after the index operation
Time Frame
changes in revision rates up to 10 years postoperatively
Secondary Outcome Measure Information:
Title
changes in patient related outcome measures (PROM)
Description
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
Time Frame
1, 2, 5, and 10 years postoperatively
Title
Changes in Range of Motion (ROM
Description
flexion, extension, radial and ulnar deviation, pronation, supination. Hand grip strength, pinch grip, lateral grip, and radiographic loosening, VAS-pain scores.
Time Frame
1, 2, 5, and 10 years postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Painful wrist arthritis Wrightington X-ray grade 2-4. Exclusion Criteria: Infection Substance abuse Mental illness.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kurt Pettersson, MD, PhD
Phone
0046196025190
Email
kurt.pettersson@orebroll.se
First Name & Middle Initial & Last Name or Official Title & Degree
Marcus Sagerfors, MD
Phone
0046196025507
Email
marcus.sagerfors@orebroll.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kurt Pettersson, MD, PhD
Organizational Affiliation
Orebro County Council, Orebro University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Hand Surgery
City
Orebro
ZIP/Postal Code
70185
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kurt Pettersson, MD, PhD
Phone
0046196025190
Email
kurt.pettersson@orebroll.se
First Name & Middle Initial & Last Name & Degree
Marcus Sagerfors, MD
Phone
0046196025507
Email
marcus.sagerfors@orebroll.se

12. IPD Sharing Statement

Learn more about this trial

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

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