Wrist ArthritisDTDPESERFNCT03977389
Total Wrist Denervation: Survival Study and Functional Outcomes
An observational study of Wrist Arthritis and Survival, run by University Hospital, Brest at 1 site in France.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Wrist Arthritis, Survival
- What is being tested?
- Total wrist denervation
- Type of treatment
- Surgery or procedure
- How many people
- 63 participants
- Where
- 1 siteFrance
- Study dates
- 20 Mar 2018to 30 Mar 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- patient undergoing total wrist denervation between January 1995 and December 2013 at Brest CHRU, performed by the same senior surgeon
Who cannot join
- patient who had another intervention at the same time (confounding factor)
- refusal expressed by the patient to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Wrist Arthritis, Survival
- Being tested
- Total wrist denervation
- Keywords
- Long-term result, Denervation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total wrist denervationProcedure or surgery
Study of the files
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Total wrist denervation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: from date of surgery until the date of first documented failure (surgical revision; pain > 3), assessed up to the inclusion date
Secondary outcomes (5)
surgery survival over time
duration (in years) of absence of surgical revision
Measured: from date of surgery until the date of documented failure (surgical revision), assessed up to the inclusion date
residual pain
numeric pain rating scale (between 0 to 10; 0 equal no pain; 10 equal "worst pain imaginable")
Measured: at the inclusion date
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)
Measured: at the inclusion date
patients' satisfaction (1)
analogue scale between 0 to 10 at the last follow-up (0 equal minimum; 10 equal maximum)
Measured: at the inclusion date
patients' satsfaction (2)
answer to "would you repeat this procedure again?"
Measured: at the inclusion date
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2019
- Study start20 Mar 2018
- Primary completion30 Mar 2018
- Study completion30 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wrist ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03977389
- Sponsor's protocol ID
- DTDPESERF (29BRC18.0122)
- Acronym
- DTDPESERF
- Status last verified
- Feb 2020
- First submitted
- 27 May 2019
- Last updated
- 28 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Total Wrist Denervation: Survival Study and Functional Outcomes
- ClinicalTrials.gov ID
- NCT03977389
- Acronym / sponsor ID
- DTDPESERF / DTDPESERF (29BRC18.0122)
- Conditions
- Wrist Arthritis, Survival
- Keywords
- Long-term result, Denervation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 20 Mar 2018 (actual)
- Primary completion
- 30 Mar 2018 (actual)
- Study completion
- 30 Mar 2018 (actual)
- First posted
- 6 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Population of the study | – | Procedure: Total wrist denervationPatient 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- patient undergoing total wrist denervation between January 1995 and December 2013 at Brest CHRU, performed by the same senior surgeon
Key exclusion criteria (2 listed)
- patient who had another intervention at the same time (confounding factor)
- refusal expressed by the patient to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Total wrist denervationStudy of the files | Procedure or surgery | Population of the study |
Primary outcome
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)
5 secondary outcomes
surgery survival over time
Time frame: 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
residual functional wrist's quality
Time frame: at the inclusion date
patients' satisfaction (1)
Time frame: at the inclusion date
patients' satsfaction (2)
Time frame: at the inclusion date
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Wrist Arthritis and Survival, run by University Hospital, Brest at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2020.