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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03378362
Other study ID # Karolinska Institute
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 31, 2017
Est. completion date August 31, 2021

Study information

Verified date March 2022
Source Karolinska Institutet
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date August 31, 2021
Est. primary completion date August 31, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion criteria 1. 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. 2. Pain is refractory to nonsurgical management such as bracing, corticosteroid injection, oral analgesics, NSAIDs, physiotherapy. Exclusion criteria 1. Rheumatoid or other inflammatory arthritis. 2. Previous wrist surgery with simultaneous PIN/AIN neurectomy. 3. Simultaneous arthritis or symptomatic instability of the distal radio ulnar (DRU) joint on the ipsilateral side. 4. Inability to co-operate with the follow-up protocol (language difficulties, severe psychiatric disorder, cognitive impairment, drug addiction). 5. Patient's wish for a definite procedure.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Partial denervation of the wrist joint
Partial denervation of the wrist (posterior and anterior interosseous neurectomy) through a single dorsal approach.

Locations

Country Name City State
Sweden Handkirurgiska kliniken Södersjukhuset Stockholm

Sponsors (1)

Lead Sponsor Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Disability of the Arm, Shoulder and Hand score (DASH) questionnaire peroperatively, 3, 6 and 12 months postoperatively
Secondary Change in Patient Related Wrist Evaluation (PRWE) questionnaire peroperatively, 3, 6 and 12 months postoperatively
Secondary Change in EQ5D questionnaire peroperatively, 3, 6 and 12 months postoperatively
Secondary 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. peroperatively, 3, 6 and 12 months postoperatively
Secondary Change in range of motion, grip strength objective physical function peroperatively, 3, 6 and 12 months postoperatively
Secondary Change in Sence Of Coherence -13 (SOC13) Questionnaire peroperatively, 3, 6 and 12 months postoperatively
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