Pain Relief and Functional Outcome After Partial Denervation of the Wrist

Wrist Arthritis Clinical Trial

Official title:

A Prospective Study on Pain Relief and Functional Outcome After Partial Denervation of the Wrist

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03378362
• Other study ID #: Karolinska Institute
• Status: Completed
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Arthritis
• Wrist Arthritis

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