Pain Relief and Functional Outcome After Partial Denervation of the Wrist

NCT03378362 | Completed

• 1 other identifier: Karolinska Institute
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Wrist Arthritis

Outcome Measures

Primary Outcomes (1)

• Change in Disability of the Arm, Shoulder and Hand score (DASH)

  questionnaire

  peroperatively, 3, 6 and 12 months postoperatively

Secondary Outcomes (5)

• Change in Patient Related Wrist Evaluation (PRWE)

  peroperatively, 3, 6 and 12 months postoperatively

• Change in EQ5D

  peroperatively, 3, 6 and 12 months postoperatively

• Change in Hospital Anxiety and Depression Scale (HADS)

  peroperatively, 3, 6 and 12 months postoperatively

• Change in range of motion, grip strength

  peroperatively, 3, 6 and 12 months postoperatively

• Change in Sence Of Coherence -13 (SOC13)

  peroperatively, 3, 6 and 12 months postoperatively

Study Arms (1)

Partial denervation of the wrist joint

EXPERIMENTAL

Patients will be operated with a partial denervation of the wrist through a single dorsal approach.

Procedure: Partial denervation of the wrist joint

Interventions

Partial denervation of the wrist joint PROCEDURE

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

Partial denervation of the wrist joint

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Karolinska Institutet: lead

Study Sites (1)

Handkirurgiska kliniken Södersjukhuset

Stockholm, 11883, Sweden

Location

Study Officials

• Maria Wilcke, MD, PhD

  Karolinska Institutet

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Principal Investigator

Study Record Dates

• First Submitted: December 13, 2017
• First Posted: December 19, 2017
• Study Start: December 31, 2017
• Primary Completion: August 31, 2021
• Study Completion: August 31, 2021
• Last Updated: March 31, 2022

Record last verified: 2022-03

Locations

SE (1)