Pain Relief and Functional Outcome After Partial Denervat... | NCT03378362

Studies
Pain Relief and Functional Outcome After Partial Denervation of the Wrist

NCT03378362

Sponsor

Karolinska Institutet

Status

Completed

Last Update Posted

Mar 31, 2022Actual

Enrollment

60Actual

Phase

Not Applicable

Conditions

Wrist Arthritis

Interventions

Partial denervation of the wrist joint

Countries

Sweden

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 31, 2017Actual

Primary Completion Date

Aug 31, 2021Actual

Completion Date

Aug 31, 2021Actual

First Submitted Date

Dec 13, 2017

First Submission Date that Met QC Criteria

Dec 18, 2017

First Posted Date

Dec 19, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 28, 2022

Last Update Posted Date

Mar 31, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
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

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Change in Patient Related Wrist Evaluation (PRWE)	questionnaire	peroperatively, 3, 6 and 12 months postoperatively
Change in EQ5D	questionnaire

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Maria Wilcke, MD, PhD	Karolinska Institutet	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Handkirurgiska kliniken Södersjukhuset		Stockholm		11883	Sweden

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided