Total Wrist Denervation: Survival Study and Functional Outcomes (DTDPESERF)

February 27, 2020 updated by: University Hospital, Brest

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.

Study Overview

Status

Completed

Intervention / Treatment

Detailed Description

The degenerative diseases of the wrist are numerous and include both post-traumatic osteoarthritis lesions and inflammatory diseases. In any case, one of the main reasons for consultation is pain. In case of inefficiency of a well-conducted medical treatment (splints, anti-inflammatories, infiltrations), surgical management remains difficult because of the multitude of treatments that can be offered: partial or total arthrodesis of the wrist, prosthetic arthroplasties, pyrocarbon implants or proximal row carpectomy. But these treatments are heavy and can potentially be sources of complications such as stiffness, loss of strength or progressive wear of the implant.

Total wrist denervation is an alternative since 1966. The original technique follows an anatomical study of the innervation of the upper limb. This technique has been proven to significantly improve pain without major after effects. Several teams demonstrated a decrease in pain associated with conserved strength and mobility, but few studies have studied the long-term results of this technique, especially on the absence of residual pain.

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

Study Type

Observational

Enrollment (Actual)

63

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Brest, France, 29609
        • CHUR de Brest

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.

Study of the files

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
survival over time
Time Frame: from date of surgery until the date of first documented failure (surgical revision; pain > 3), assessed up to the inclusion date
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
surgery survival over time
Time Frame: from date of surgery until the date of documented failure (surgical revision), assessed up to the inclusion date
duration (in years) of absence of surgical revision
from date of surgery until the date of documented failure (surgical revision), assessed up to the inclusion date
residual pain
Time Frame: at the inclusion date
numeric pain rating scale (between 0 to 10; 0 equal no pain; 10 equal "worst pain imaginable")
at the inclusion date
residual functional wrist's quality
Time Frame: at the inclusion date
Result of the DASH (Disabilities of the Arm and Shoulder Disabilities) score (between 0 to 100; 0 equal better result; 100 equal worst result)
at the inclusion date
patients' satisfaction (1)
Time Frame: at the inclusion date
analogue scale between 0 to 10 at the last follow-up (0 equal minimum; 10 equal maximum)
at the inclusion date
patients' satsfaction (2)
Time Frame: at the inclusion date
answer to "would you repeat this procedure again?"
at the inclusion date

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 20, 2018

Primary Completion (ACTUAL)

March 30, 2018

Study Completion (ACTUAL)

March 30, 2018

Study Registration Dates

First Submitted

May 27, 2019

First Submitted That Met QC Criteria

June 5, 2019

First Posted (ACTUAL)

June 6, 2019

Study Record Updates

Last Update Posted (ACTUAL)

February 28, 2020

Last Update Submitted That Met QC Criteria

February 27, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DTDPESERF (29BRC18.0122)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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