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

NCT ID: NCT02080663

Last Updated: 2014-03-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-03-31

Study Completion Date

2014-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Wrist Arthritis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Proximal row carpectomy

Proximal row carpectomy

Proximal row carpectomy

Intervention Type PROCEDURE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Proximal row carpectomy

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* All patients who underwent a Proximal row carpectomy

Exclusion Criteria

* Bilateral procedure
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University Hospital Pellenberg

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Maarten Van Nuffel

Fellow Upper Limb Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Maarten Van Nuffel, M.D.

Role: PRINCIPAL_INVESTIGATOR

Universitaire Ziekenhuizen KU Leuven

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University Hospitals Leuven

Leuven, Vlaams-Brabant, Belgium

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Belgium

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

PRC Van Nuffel De Smet

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.