DTDPESERF: Total Wrist Denervation: Survival Study and Functional Outcomes

Sponsor
University Hospital, Brest (Other)
Overall Status
Completed
CT.gov ID
NCT03977389
Collaborator
(none)
63
1
10
191.8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Total wrist denervation

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 Design

Study Type:
Observational
Actual Enrollment :
63 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Total Wrist Denervation: Survival Study and Functional Outcomes
Actual Study Start Date :
Mar 20, 2018
Actual Primary Completion Date :
Mar 30, 2018
Actual Study Completion Date :
Mar 30, 2018

Arms and Interventions

Arm 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.

Procedure: Total wrist denervation
Study of the files

Outcome Measures

Primary Outcome Measures

  1. survival over time [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)

Secondary Outcome Measures

  1. surgery survival over time [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

  2. residual pain [at the inclusion date]

    numeric pain rating scale (between 0 to 10; 0 equal no pain; 10 equal "worst pain imaginable")

  3. residual functional wrist's quality [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)

  4. patients' satisfaction (1) [at the inclusion date]

    analogue scale between 0 to 10 at the last follow-up (0 equal minimum; 10 equal maximum)

  5. patients' satsfaction (2) [at the inclusion date]

    answer to "would you repeat this procedure again?"

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 CHUR de Brest Brest France 29609

Sponsors and Collaborators

  • University Hospital, Brest

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Hospital, Brest
ClinicalTrials.gov Identifier:
NCT03977389
Other Study ID Numbers:
  • DTDPESERF (29BRC18.0122)
First Posted:
Jun 6, 2019
Last Update Posted:
Feb 28, 2020
Last Verified:
Feb 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University Hospital, Brest
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 28, 2020