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 |
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Wrist Arthritis Survival | Procedure: Total wrist denervation |
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 |
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 |
Group/Cohort | Intervention/treatment |
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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
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Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
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.
Inclusion Criteria:
Exclusion Criteria:
France | |
CHUR de Brest | |
Brest, France, 29609 |
Tracking Information | |||||
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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 |
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)
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Original Primary Outcome Measures | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures |
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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. |
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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. |
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Study Type | Observational | ||||
Study Design | Observational Model: Cohort Time Perspective: Retrospective |
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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. |
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Condition |
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Intervention | Procedure: Total wrist denervation
Study of the files
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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
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status | Completed | ||||
Actual Enrollment |
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:
Exclusion Criteria:
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Sex/Gender |
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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 |
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IPD Sharing Statement |
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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 |