- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03977389
Total Wrist Denervation: Survival Study and Functional Outcomes (DTDPESERF)
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
Conditions
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
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
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Brest, France, 29609
- CHUR de Brest
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
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
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
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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
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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)
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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
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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
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numeric pain rating scale (between 0 to 10; 0 equal no pain; 10 equal "worst pain imaginable")
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at the inclusion date
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residual functional wrist's quality
Time Frame: at the inclusion date
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Result of the DASH (Disabilities of the Arm and Shoulder Disabilities) score (between 0 to 100; 0 equal better result; 100 equal worst result)
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at the inclusion date
|
patients' satisfaction (1)
Time Frame: at the inclusion date
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analogue scale between 0 to 10 at the last follow-up (0 equal minimum; 10 equal maximum)
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at the inclusion date
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patients' satsfaction (2)
Time Frame: at the inclusion date
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answer to "would you repeat this procedure again?"
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at the inclusion date
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- DTDPESERF (29BRC18.0122)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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