Total Wrist Denervation: Survival Study and Functional Outcomes

NCT03977389 | Completed

• 1 other identifier: DTDPESERF (29BRC18.0122)
• Study Type: observational
• Target: 63
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to evaluate the long-term effectiveness of total wrist denervation on pain by assessing the surgery survival. The residual functional wrist's quality and the patients' satisfaction will also be evaluate.

Conditions

Wrist Arthritis; Survival

Keywords

Long-term result; Denervation

Outcome Measures

Primary Outcomes (1)

• survival over time

  duration (in years) of absence of surgical revision, and residual pain \< or = 3 on a pain numerical scale (0 to 10, WHO criteria for mild pain)

  from date of surgery until the date of first documented failure (surgical revision; pain > 3), assessed up to the inclusion date

Secondary Outcomes (5)

• surgery survival over time

  from date of surgery until the date of documented failure (surgical revision), assessed up to the inclusion date

• residual pain

  at the inclusion date

• residual functional wrist's quality

  at the inclusion date

• patients' satisfaction (1)

  at the inclusion date

• patients' satsfaction (2)

  at the inclusion date

Study Arms (1)

Population of the study

Patient undergoing total wrist denervation between January 1995 and December 2013 at Brest CHRU, performed by the same senior surgeon. Total wrist denervation is a routine procedure in orthopedic surgery for wrist arthritis.

Procedure: Total wrist denervation

Interventions

Total wrist denervation PROCEDURE

Study of the files

Population of the study

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients undergoing total wrist denervation (TWD) between January 1995 and December 2013 at Brest CHRU, performed by the same senior surgeon. TWD was indicated in a routine procedure for degenerative diseases of the wrist (post-traumatic osteoarthritis lesions and inflammatory diseases). The aetiologies are varied: SLAC-wrist, distal radius fractures, SNAC-wrist, Kienböck disease, chondrocalcinosis, peri-lunar luxation of the carpus, rheumatoid arthritis, haemochromatoses, ruptures of the luno-triquetral ligament.

You may qualify if:

• patient undergoing total wrist denervation between January 1995 and December 2013 at Brest CHRU, performed by the same senior surgeon

You may not qualify if:

• patient who had another intervention at the same time (confounding factor)
• refusal expressed by the patient to participate in the study

Sponsors & Collaborators

• University Hospital, Brest: lead

Study Sites (1)

CHUR de Brest

Brest, 29609, France

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2019
• First Posted: June 6, 2019
• Study Start: March 20, 2018
• Primary Completion: March 30, 2018
• Study Completion: March 30, 2018
• Last Updated: February 28, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)