Clinical trial NCT02080663: Long-term Outcome of Proximal Row Carpectomy. Influence of the Shape of the Capitate
Official title: Long-term Outcome of Proximal Row Carpectomy. Influence of the Shape of the Capitate
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Wrist Arthritis
Keywords: carpectomy, proximal row, long-term, wrist, arthritis
Lead sponsor: University Hospital Pellenberg
Sponsor class: OTHER
First posted: 2014-03-06
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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

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.

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.

Eligibility criteria: Inclusion Criteria:

* All patients who underwent a Proximal row carpectomy

Exclusion Criteria:

* Bilateral procedure

Primary outcomes:
measure: quick DASH score
timeFrame: more than 10 year after operation
Secondary outcomes:
measure: Arthritis between capitate and lunate fossa
timeFrame: 10 years after operation
Other outcomes:
measure: Range of movement
timeFrame: 10 years after operation
Locations:
city: Leuven
country: Belgium
facility: University Hospitals Leuven
state: Vlaams-Brabant
Study officials:
affiliation: Universitaire Ziekenhuizen KU Leuven
name: Maarten Van Nuffel, M.D.
role: PRINCIPAL_INVESTIGATOR
References: