Wrist ArthritisNCT03378362
Pain Relief and Functional Outcome After Partial Denervation of the Wrist
A study testing Partial denervation of the wrist joint in people with Wrist Arthritis, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
Prospective study on the effect of partial wrist denervation (ie combined anterior and posterior interosseous neurectomy) on pain relief on functional outcome in patient with wrist osteoarthritis. The impact of psychological factors on postoperative outcome will be studied. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Wrist Arthritis
- What is being tested?
- Partial denervation of the wrist joint
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSweden
- Study dates
- 31 Dec 2017to 31 Aug 2021
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic wrist pain (≥6 months) due to posttraumatic arthritis after distal radius fracture or SLAC/SNAC arthritis or arthritis due to Mb Preiser/Mb Kienböck where surgical unloading of the bone isn't possible.
- Pain is refractory to nonsurgical management such as bracing, corticosteroid injection, oral analgesics, NSAIDs, physiotherapy.
Who cannot join
- Rheumatoid or other inflammatory arthritis.
- Previous wrist surgery with simultaneous PIN/AIN neurectomy.
- Simultaneous arthritis or symptomatic instability of the distal radio ulnar (DRU) joint on the ipsilateral side.
- Inability to co-operate with the follow-up protocol (language difficulties, severe psychiatric disorder, cognitive impairment, drug addiction).
- Patient's wish for a definite procedure.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Study on Pain Relief and Functional Outcome After Partial Denervation of the Wrist
Prospective study on the effect of partial wrist denervation (ie combined anterior and posterior interosseous neurectomy) on pain relief on functional outcome in patient with wrist osteoarthritis. The impact of psychological factors on postoperative outcome will be studied.
- Conditions
- Wrist Arthritis
- Being tested
- Partial denervation of the wrist joint
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Partial denervation of the wrist jointProcedure or surgery
Partial denervation of the wrist (posterior and anterior interosseous neurectomy) through a single dorsal approach.
| Study group | Role | What they receive |
|---|---|---|
| Partial denervation of the wrist joint | Experimental | Patients will be operated with a partial denervation of the wrist through a single dorsal approach. Receives: Procedure: Partial denervation of the wrist joint |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Disability of the Arm, Shoulder and Hand score (DASH)
questionnaire
Measured: peroperatively, 3, 6 and 12 months postoperatively
Secondary outcomes (5)
Change in Patient Related Wrist Evaluation (PRWE)
questionnaire
Measured: peroperatively, 3, 6 and 12 months postoperatively
Change in EQ5D
questionnaire
Measured: peroperatively, 3, 6 and 12 months postoperatively
Change in Hospital Anxiety and Depression Scale (HADS)
questionnaire. Determines the levels of anxiety and depression. 14 item scale that generates ordinal data. Seven items relate to anxiety and seven to depression. Each item is scored from 0-3, which means that a person can score between 0-21 for either depression or anxiety. A score of 11 or above on either scale in considered to repressent depression or anxiety.
Measured: peroperatively, 3, 6 and 12 months postoperatively
Change in range of motion, grip strength
objective physical function
Measured: peroperatively, 3, 6 and 12 months postoperatively
Change in Sence Of Coherence -13 (SOC13)
Questionnaire
Measured: peroperatively, 3, 6 and 12 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2017
- Study start31 Dec 2017
- Primary completion31 Aug 2021
- Study completion31 Aug 2021
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.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elin Swärd, Karolinska Institutet
- Investigators
- Maria Wilcke, MD, PhD, Study director, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03378362
- Sponsor's protocol ID
- Karolinska Institute
- Status last verified
- Mar 2022
- First submitted
- 13 Dec 2017
- Last updated
- 31 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study on Pain Relief and Functional Outcome After Partial Denervation of the Wrist
- ClinicalTrials.gov ID
- NCT03378362
- Acronym / sponsor ID
- Karolinska Institute
- Conditions
- Wrist Arthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- 31 Dec 2017 (actual)
- Primary completion
- 31 Aug 2021 (actual)
- Study completion
- 31 Aug 2021 (actual)
- First posted
- 19 Dec 2017 (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.
Prospective study on the effect of partial wrist denervation (ie combined anterior and posterior interosseous neurectomy) on pain relief on functional outcome in patient with wrist osteoarthritis. The impact of psychological factors on postoperative outcome will be studied.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Partial denervation of the wrist joint | Experimental | Procedure: Partial denervation of the wrist jointPatients will be operated with a partial denervation of the wrist through a single dorsal approach. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Chronic wrist pain (≥6 months) due to posttraumatic arthritis after distal radius fracture or SLAC/SNAC arthritis or arthritis due to Mb Preiser/Mb Kienböck where surgical unloading of the bone isn't possible.
- Pain is refractory to nonsurgical management such as bracing, corticosteroid injection, oral analgesics, NSAIDs, physiotherapy.
Key exclusion criteria (5 listed)
- Rheumatoid or other inflammatory arthritis.
- Previous wrist surgery with simultaneous PIN/AIN neurectomy.
- Simultaneous arthritis or symptomatic instability of the distal radio ulnar (DRU) joint on the ipsilateral side.
- Inability to co-operate with the follow-up protocol (language difficulties, severe psychiatric disorder, cognitive impairment, drug addiction).
- Patient's wish for a definite procedure.
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 |
|---|---|---|
| Partial denervation of the wrist jointPartial denervation of the wrist (posterior and anterior interosseous neurectomy) through a single dorsal approach. | Procedure or surgery | Partial denervation of the wrist joint |
Primary outcome
Change in Disability of the Arm, Shoulder and Hand score (DASH)
Time frame: peroperatively, 3, 6 and 12 months postoperatively
questionnaire
5 secondary outcomes
Change in Patient Related Wrist Evaluation (PRWE)
Time frame: peroperatively, 3, 6 and 12 months postoperatively
Change in EQ5D
Time frame: peroperatively, 3, 6 and 12 months postoperatively
Change in Hospital Anxiety and Depression Scale (HADS)
Time frame: peroperatively, 3, 6 and 12 months postoperatively
Change in range of motion, grip strength
Time frame: peroperatively, 3, 6 and 12 months postoperatively
Change in Sence Of Coherence -13 (SOC13)
Time frame: peroperatively, 3, 6 and 12 months postoperatively
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 31 Mar 2022.
- Individual participant dataSharing planned: Undecided
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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.
Maria Wilcke, MD, PhD study director
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Partial denervation of the wrist joint in people with Wrist Arthritis, run by Karolinska Institutet at 1 site in Sweden.
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 2 inclusion and 5 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 31 Mar 2022. 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 Sweden. 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?
Change in Disability of the Arm, Shoulder and Hand score (DASH) (time frame: peroperatively, 3, 6 and 12 months postoperatively). 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 31 Mar 2022.