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出境医 / 临床实验 / Total Wrist Denervation: Survival Study and Functional Outcomes (DTDPESERF)

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

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
Wrist Arthritis Survival 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
Layout table for study information
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 : March 20, 2018
Actual Primary Completion Date : March 30, 2018
Actual Study Completion Date : March 30, 2018
Arms 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.

Procedure: Total wrist denervation
Study of the files

Outcome Measures
Primary Outcome Measures :
  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 Outcome Measures :
  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?"


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Criteria

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
Layout table for location information
France
CHUR de Brest
Brest, France, 29609
Sponsors and Collaborators
University Hospital, Brest
Tracking Information
First Submitted Date May 27, 2019
First Posted Date June 6, 2019
Last Update Posted Date February 28, 2020
Actual Study Start Date March 20, 2018
Actual Primary Completion Date March 30, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 5, 2019)
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)
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: June 5, 2019)
  • 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
  • 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")
  • 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)
  • 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)
  • patients' satsfaction (2) [ Time Frame: at the inclusion date ]
    answer to "would you repeat this procedure again?"
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Total Wrist Denervation: Survival Study and Functional Outcomes
Official Title Total Wrist Denervation: Survival Study and Functional Outcomes
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.

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
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.

Condition
  • Wrist Arthritis
  • Survival
Intervention Procedure: Total wrist denervation
Study of the files
Study Groups/Cohorts 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.

Intervention: Procedure: Total wrist denervation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: June 5, 2019)
63
Original Actual Enrollment Same as current
Actual Study Completion Date March 30, 2018
Actual Primary Completion Date March 30, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT03977389
Other Study ID Numbers DTDPESERF (29BRC18.0122)
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party University Hospital, Brest
Study Sponsor University Hospital, Brest
Collaborators Not Provided
Investigators Not Provided
PRS Account University Hospital, Brest
Verification Date February 2020

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