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

Wrist Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02080663
• Other study ID #: PRC Van Nuffel De Smet
• Status: Enrolling by invitation
• Phase: N/A
• First received: March 4, 2014
• Last updated: March 6, 2014
• Start date: March 2014
• Est. completion date: July 2014

Study information

• Verified date: March 2014
• Source: University Hospital Pellenberg
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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:

• 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 60
• Est. completion date: July 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• All patients who underwent a Proximal row carpectomy

Exclusion Criteria:

• Bilateral procedure

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Wrist Arthritis

Intervention

Procedure:
• Proximal row carpectomy

Locations

Country	Name	City	State
Belgium	University Hospitals Leuven	Leuven	Vlaams-Brabant

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Pellenberg

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Range of movement	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	No
Primary	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	No
Secondary	Arthritis between capitate and lunate fossa	radiographic evaluation of arthritis in the wrist: 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	No