Total Wrist Denervation: Survival Study and Functional Outcomes

Survival Clinical Trial

— DTDPESERF  

Official title:

Total Wrist Denervation: Survival Study and Functional Outcomes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03977389
• Other study ID #: DTDPESERF (29BRC18.0122)
• Status: Completed
• Start date: March 20, 2018
• Est. completion date: March 30, 2018

Study information

• Verified date: February 2020
• Source: University Hospital, Brest
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: March 30, 2018
• Est. primary completion date: March 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Survival
• Wrist Arthritis

Intervention

Procedure:
• Total wrist denervation
Study of the files

Locations

Country	Name	City	State
France	CHUR de Brest	Brest

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	survival over time	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)	from date of surgery until the date of first documented failure (surgical revision; pain > 3), assessed up to the inclusion date
Secondary	surgery survival over time	duration (in years) of absence of surgical revision	from date of surgery until the date of documented failure (surgical revision), assessed up to the inclusion date
Secondary	residual pain	numeric pain rating scale (between 0 to 10; 0 equal no pain; 10 equal "worst pain imaginable")	at the inclusion date
Secondary	residual functional wrist's quality	Result of the DASH (Disabilities of the Arm and Shoulder Disabilities) score (between 0 to 100; 0 equal better result; 100 equal worst result)	at the inclusion date
Secondary	patients' satisfaction (1)	analogue scale between 0 to 10 at the last follow-up (0 equal minimum; 10 equal maximum)	at the inclusion date
Secondary	patients' satsfaction (2)	answer to "would you repeat this procedure again?"	at the inclusion date