Pain Relief and Functional Outcome After Partial Denervation of the Wrist

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.

Study Overview

• Status: Completed
• Conditions: Wrist Arthritis
• Intervention / Treatment: Procedure: Partial denervation of the wrist joint

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Stockholm, Sweden, 11883
    • Handkirurgiska kliniken Södersjukhuset

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Partial denervation of the wrist joint; Patients will be operated with a partial denervation of the wrist through a single dorsal approach.	Procedure: Partial denervation of the wrist joint; Partial denervation of the wrist (posterior and anterior interosseous neurectomy) through a single dorsal approach.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Disability of the Arm, Shoulder and Hand score (DASH)	questionnaire	peroperatively, 3, 6 and 12 months postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Patient Related Wrist Evaluation (PRWE)	questionnaire	peroperatively, 3, 6 and 12 months postoperatively
Change in EQ5D	questionnaire	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.	peroperatively, 3, 6 and 12 months postoperatively
Change in range of motion, grip strength	objective physical function	peroperatively, 3, 6 and 12 months postoperatively
Change in Sence Of Coherence -13 (SOC13)	Questionnaire	peroperatively, 3, 6 and 12 months postoperatively

Collaborators and Investigators

• Sponsor: Karolinska Institutet
• Investigators: Study Director: Maria Wilcke, MD, PhD, Karolinska Institutet

Study record dates

Study Major Dates

• Study Start (Actual): December 31, 2017
• Primary Completion (Actual): August 31, 2021
• Study Completion (Actual): August 31, 2021

Study Registration Dates

• First Submitted: December 13, 2017
• First Submitted That Met QC Criteria: December 18, 2017
• First Posted (Actual): December 19, 2017

Study Record Updates

• Last Update Posted (Actual): March 31, 2022
• Last Update Submitted That Met QC Criteria: March 28, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Arthritis
• Other Study ID Numbers: Karolinska Institute

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No