Long-term Outcome of Proximal Row Carpectomy. Influence of the Shape of the Capitate

March 6, 2014 updated by: Maarten Van Nuffel, University Hospital Pellenberg

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

We invite all patients who underwent a PRC at our institution with a follow-up of more than 10 years for review.

Questions

  • VAS pain in rest and during activity

    • Pain is quantified as none, minimal (pain with strenuous activity), moderate (pain with daily activity), or severe (pain at rest).
    • If pain, use of analgetics, splint, …
  • quick DASH
  • patient related wrist evaluation (PRWE) score. form-36 (SF-36) general health status outcome ?
  • Satisfaction, do it again?
  • Complications? Re-operations?
  • Return to work after operation, which job (manual labor?) changed job due to wrist problems? Worker's compensation claims?

Clinical review

  • grip force + other side to compare (Jamar Dynamometer)
  • pinch grip + other side to compare
  • range of motion measurement:

    • absolute and compared to other side
    • flexion-extension, ulnar-radial deviation and prosupination

Radiography:

  • Standard anterioposterior and lateral wrist radiography performed to evaluate the onset or degree of arthritis.

    o Radiocapitate arthrosis grading:

    • None
    • Minimal (joint space narrowing alone),
    • Moderate (joint space narrowing with adjacent subchondral sclerosis)
    • severe (bone collapse, erosion, or subchondral cyst formation)
  • Oldest radiography of each patient was retrieved and the shape of the capitate evaluated.
  • If available, a pre-operative MRI scan could also be interpreted. (Probably no MRI's available, but MRI gives a better indication of the shape of the capitate than plain X-ray).
  • Review: documentation of intra-operative findings concerning capitate and lunate fossa.

Statistical analysis

  • Student's t-test on the numerical data
  • Wilcoxon signed- rank test on the visual analog scales
  • Differences significant at p < .05. Two-tailed tests in all cases.
  • Subgroups according to initial diagnosis
  • Compare results with the initial follow-up to evaluate the prospective value of this follow-up moment.

Study Type

Observational

Enrollment (Anticipated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Vlaams-Brabant
      • Leuven, Vlaams-Brabant, Belgium, 3000
        • University Hospitals Leuven

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-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

Description

Inclusion Criteria:

  • All patients who underwent a Proximal row carpectomy

Exclusion Criteria:

  • Bilateral procedure

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Proximal row carpectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
quick DASH score
Time Frame: more than 10 year after operation
The Disability of Arm, Shoulder and Hand score is a standardised outcome measure for upper limb evaluation.
more than 10 year after operation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Arthritis between capitate and lunate fossa
Time Frame: 10 years after operation

radiographic evaluation of arthritis in the wrist:

  • None
  • Minimal (joint space narrowing alone),
  • Moderate (joint space narrowing with adjacent subchondral sclerosis)
  • Severe (bone collapse, erosion, or subchondral cyst formation)
10 years after operation

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Range of movement
Time Frame: 10 years after operation
clinical measurement with a goniometer of the flexion, extension, ulnar and radial deviation and pronation and supination + comparison to the other, uninvolved wrist
10 years after operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Maarten Van Nuffel, M.D., Universitaire Ziekenhuizen KU Leuven

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2014

Primary Completion (Anticipated)

June 1, 2014

Study Completion (Anticipated)

July 1, 2014

Study Registration Dates

First Submitted

March 4, 2014

First Submitted That Met QC Criteria

March 5, 2014

First Posted (Estimate)

March 6, 2014

Study Record Updates

Last Update Posted (Estimate)

March 7, 2014

Last Update Submitted That Met QC Criteria

March 6, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRC Van Nuffel De Smet

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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