NCT02080663

Brief Summary

In cases of severe arthritis of the wrist, surgical removal of the scaphoid, lunate and triquetrum bones or proximal row carpectomy (PRC) is a well-known procedure. This procedure converts the wrist in a simple hinged joint but allows us to preserve a certain range of motion in the wrist. One of the main disadvantages of PRC is the risk of developing arthritis between the head of the capitate and the lunate fossa. The long-term follow-up of this procedure has always been a reason for concern. The investigators set up this retrospective study to evaluate the long-term results of the procedure in the investigators institution. Also, the shape of the head of the capitate may play a role in the development of arthritis. A more round shape could distribute the forces more equally and thus prevent the progression of cartilage damage The study hypothesis is:

  • PRC preserves range of motion and force in the long term (more than 10 years postoperatively).
  • A more round head of the capitate is associated with an increased risk of developing arthritis in the new joint.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2014

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

March 1, 2014

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

March 4, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 6, 2014

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

March 7, 2014

Status Verified

March 1, 2014

Enrollment Period

3 months

First QC Date

March 4, 2014

Last Update Submit

March 6, 2014

Conditions

Keywords

carpectomy, proximal row, long-term, wrist, arthritis

Outcome Measures

Primary Outcomes (1)

  • quick DASH score

    The Disability of Arm, Shoulder and Hand score is a standardised outcome measure for upper limb evaluation.

    more than 10 year after operation

Secondary Outcomes (1)

  • Arthritis between capitate and lunate fossa

    10 years after operation

Other Outcomes (1)

  • Range of movement

    10 years after operation

Study Arms (1)

Proximal row carpectomy

Proximal row carpectomy

Procedure: Proximal row carpectomy

Interventions

Proximal row carpectomy

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients who underwent a Proximal row carpectomy in our institution more than 10 year ago will be contacted for review

You may qualify if:

  • All patients who underwent a Proximal row carpectomy

You may not qualify if:

  • Bilateral procedure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospitals Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

Location

MeSH Terms

Conditions

Arthritis

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal Diseases

Study Officials

  • Maarten Van Nuffel, M.D.

    Universitaire Ziekenhuizen KU Leuven

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Fellow Upper Limb Surgery

Study Record Dates

First Submitted

March 4, 2014

First Posted

March 6, 2014

Study Start

March 1, 2014

Primary Completion

June 1, 2014

Study Completion

July 1, 2014

Last Updated

March 7, 2014

Record last verified: 2014-03

Locations