NCT01906996

Brief Summary

There are two types of interventions to treat a post-traumatic wrist osteoarthritis: the proximal row carpectomy and the four corner fusion. They are used to reduce pain and to maintain the mobility. In previous studies are shown that the proximal row carpectomy shows a better mobility of the wrist postoperatively, whereas the four corner fusion has lower progression of radiocarpale osteoarthritis. The purpose of this study is to compare the clinical, radiological and subjective outcomes after the treatment with a proximal row carpectomy or a four corner fusion.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
114

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2013

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2013

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

July 11, 2013

Completed
13 days until next milestone

First Posted

Study publicly available on registry

July 24, 2013

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
Last Updated

February 27, 2014

Status Verified

February 1, 2014

Enrollment Period

6 months

First QC Date

July 11, 2013

Last Update Submit

February 26, 2014

Conditions

Outcome Measures

Primary Outcomes (1)

  • Range of motion of the wrist

    measurements of flexion/extension,supination/pronation and radial-/ulnarduction of the wrist

    participants will be followed up by an expected average of 4.5 years

Secondary Outcomes (1)

  • complication rate

    participants will be followed up by an expected average of 4.5 years

Other Outcomes (5)

  • grip strength

    participants will be followed up by an expected average of 4.5 years

  • Patient-Rated Wirst Evaluation (PRWE)

    participants will be followed up by an expected average of 4.5 years

  • Michigan Hand Outcomes Questionnaire (MHQ)

    participants will be followed up by an expected average of 4.5 years

  • +2 more other outcomes

Study Arms (2)

proximal row carpectomy

patients were treated with a proximal row carpectomy

Procedure: proximal row carpectomy

four corner fusion

patients were treated with a four corner fusion

Procedure: four corner fusion

Interventions

excision of the scaphoid, lunate and triquetrum

proximal row carpectomy

excision of the scaphoid and stiffening of the lunate, capitate and triquetrum by a plate

four corner fusion

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients with a post-traumatic wrist osteoarthritis, who are treated with a proximal row carpectomy or a four corner fusion

You may qualify if:

  • post-traumatic wrist osteoarthritis
  • treated with a proximal row carpectomy or four corner fusion
  • signed written informed consent

You may not qualify if:

  • no knowledge of German

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Schulthess Klinik

Zurich, Canton of Zurich, 8008, Switzerland

Location

Study Officials

  • Daniel B Herren, Dr. med.

    Schulthess Klinik

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. med.

Study Record Dates

First Submitted

July 11, 2013

First Posted

July 24, 2013

Study Start

July 1, 2013

Primary Completion

January 1, 2014

Study Completion

January 1, 2014

Last Updated

February 27, 2014

Record last verified: 2014-02

Locations