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Completed

NCT Number: NCT03977389

Total Wrist Denervation: Survival Study and Functional Outcomes

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.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

CHUR de Brest

Brest, 29609, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Total wrist denervation

Procedure

Study of the files

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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

  2. 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")

  3. 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)

  4. 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)

  5. patients' satsfaction (2)

    Time frame: at the inclusion date

    answer to "would you repeat this procedure again?"

Sponsors and collaborators

Lead sponsor

University Hospital, Brest

Other

Registry information

Acronym: DTDPESERF

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jun 6, 2019
Registry last updated
Feb 28, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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