Clinical trial NCT03977389: Total Wrist Denervation: Survival Study and Functional Outcomes
Official title: Total Wrist Denervation: Survival Study and Functional Outcomes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Wrist Arthritis
Survival
Keywords: Long-term result
Denervation
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2019-06-06
Enrollment: 63
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.

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

Primary outcomes:
measure: survival over time
timeFrame: from date of surgery until the date of first documented failure (surgical revision; pain > 3), assessed up to the inclusion date
Secondary outcomes:
measure: surgery survival over time
timeFrame: from date of surgery until the date of documented failure (surgical revision), assessed up to the inclusion date
measure: residual pain
timeFrame: at the inclusion date
measure: residual functional wrist's quality
timeFrame: at the inclusion date
measure: patients' satisfaction (1)
timeFrame: at the inclusion date
measure: patients' satsfaction (2)
timeFrame: at the inclusion date
Other outcomes:
Locations:
city: Brest
country: France
facility: CHUR de Brest
Study officials:
References: