Clinical trial NCT02336009: 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
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Rheumatoid Arthritis
Osteoarthritis
Keywords: wrist arthritis
total wrist arthroplasty
Lead sponsor: Örebro University, Sweden
Sponsor class: OTHER
Collaborators: name: Örebro Läns Landsting
First posted: 2015-01-12
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Infection
* Substance abuse
* Mental illness.

Primary outcomes:
measure: revision rate
timeFrame: changes in revision rates up to 10 years postoperatively
Secondary outcomes:
measure: changes in patient related outcome measures (PROM)
timeFrame: 1, 2, 5, and 10 years postoperatively
measure: Changes in Range of Motion (ROM
timeFrame: 1, 2, 5, and 10 years postoperatively
Other outcomes:
Locations:
city: Orebro
country: Sweden
facility: Department of Hand Surgery
Study officials:
affiliation: Orebro County Council, Orebro University
name: Kurt Pettersson, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: