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Pain Relief and Functional Outcome After Partial Denervation of the Wrist

Primary Purpose

Wrist Arthritis

Status

Completed

Phase

Not Applicable

Locations

Sweden

Study Type

Interventional

Intervention

Partial denervation of the wrist joint

About this trial

This is an interventional treatment trial for Wrist Arthritis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria

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.

Exclusion criteria

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.

Sites / Locations

Handkirurgiska kliniken Södersjukhuset

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Partial denervation of the wrist joint

Arm Description

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

Outcomes

Primary Outcome Measures

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

questionnaire

Secondary Outcome Measures

Change in Patient Related Wrist Evaluation (PRWE)

questionnaire

Change in EQ5D

questionnaire

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.

Change in range of motion, grip strength

objective physical function

Change in Sence Of Coherence -13 (SOC13)

Questionnaire

Full Information

NCT ID

NCT03378362

First Posted

December 13, 2017

Last Updated

March 28, 2022

Sponsor

Karolinska Institutet

1. Study Identification

Unique Protocol Identification Number

NCT03378362

Brief Title

Pain Relief and Functional Outcome After Partial Denervation of the Wrist

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2022

Overall Recruitment Status

Completed

Study Start Date

December 31, 2017 (Actual)

Primary Completion Date

August 31, 2021 (Actual)

Study Completion Date

August 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Karolinska Institutet

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Wrist Arthritis

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Partial denervation of the wrist joint

Arm Type

Experimental

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

Partial denervation of the wrist joint

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Description

questionnaire

Time Frame

peroperatively, 3, 6 and 12 months postoperatively

Secondary Outcome Measure Information:

Title

Change in Patient Related Wrist Evaluation (PRWE)

Description

questionnaire

Time Frame

peroperatively, 3, 6 and 12 months postoperatively

Title

Change in EQ5D

Description

questionnaire

Time Frame

peroperatively, 3, 6 and 12 months postoperatively

Title

Change in Hospital Anxiety and Depression Scale (HADS)

Description

Time Frame

peroperatively, 3, 6 and 12 months postoperatively

Title

Change in range of motion, grip strength

Description

objective physical function

Time Frame

peroperatively, 3, 6 and 12 months postoperatively

Title

Change in Sence Of Coherence -13 (SOC13)

Description

Questionnaire

Time Frame

peroperatively, 3, 6 and 12 months postoperatively

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion criteria 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. Exclusion criteria 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Maria Wilcke, MD, PhD

Organizational Affiliation

Karolinska Institutet

Official's Role

Study Director

Facility Information:

Facility Name

Handkirurgiska kliniken Södersjukhuset

City

Stockholm

ZIP/Postal Code

11883

Country

Sweden

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

Pain Relief and Functional Outcome After Partial Denervation of the Wrist

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