Radioscapholunate Fusions After Wrist Trauma

Posttraumatic Radiocarpal Osteoarthritis Clinical Trial

— Radioscapho  

Official title:

Radioscapholunate Fusions After Wrist Trauma: Long-term Clinical and Radiographic Results.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03850249
• Other study ID #: RECHMPL19_0010
• Status: Completed
• Start date: January 1, 2018
• Est. completion date: May 31, 2018

Study information

• Verified date: December 2020
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The investigators conduced a clinical trial to evaluate the clinical and radiographic results after radioscapholunate fusion in case of posttraumatic radiocarpal osteoarthritis.

Because of poor clinical result, many authors upgrade the procedure including excision of the distal pole of the scaphoid and later excision of the entire triquetrum.

Only one study compared the three procedures in 17 patients. The investigators performed the same comparison in 85 patients with a mean follow up of 9,1 years (1-23)

Description:

The investigators compared three populations: patients with radioscapholunate (RSL) fusion alone, patients with RSLfusion and distal scaphoid excision and patient with RSL fusion, distal scaphoid excision and excision of the triquetrum.

The investigators performed clinical (pain, grasp strength, wrist motion), functional and radiographic (midcarpal osteoarthritis and radiocarpal nonunions) evaluation

Recruitment information / eligibility

• Status: Completed
• Enrollment: 85
• Est. completion date: May 31, 2018
• Est. primary completion date: May 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

• posttraumatic radiocarpal osteoarthritis

• Patients who underwent radioscapholunate fusion

Exclusion criteria:

• Patients with radiocarpal osteoarthritis due to rheumatoid or inflammatory disease and Kienböck disease

• Patients with posttraumatic radiocarpal osteoarthritis managed with other surgery

Related Conditions & MeSH terms

• Osteoarthritis
• Posttraumatic Radiocarpal Osteoarthritis

Locations

Country	Name	City	State
France	Uhmontpellier	Montpellier

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Montpellier	Nancy University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	presence of mediocarpal osteoarthritis	To evaluate the long-term radiographic results of post-traumatic radio scapholunate	1 day
Primary	presence of scapho-trapezoidal trapezoid	To evaluate the long-term radiographic results of post-traumatic radio scapholunate	1 day
Primary	presence of non-consolidation of radio-scapho-lunar arthrodesis	To evaluate the long-term radiographic results of post-traumatic radio scapholunate	1 day
Secondary	Assess overall survival	To evaluate the overall survival (excluding total wrist arthrodesis) of post-traumatic radio scapholunate	1 day
Secondary	the prognostic factors of good clinical	To evaluate the prognostic factors of good clinical (ie absence of osteoarthritis or good consolidation of arthrodesis)	1 day
Secondary	the prognostic factors of radiographic evolution	To evaluate the prognostic factors of radiographic evolution (ie absence of osteoarthritis or good consolidation of arthrodesis)	1 day