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Clinical Trials/NCT03378362
NCT03378362CompletedNot Applicable

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

Karolinska Institutet1 site in 1 country60 target enrollmentStarted: December 31, 2017Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
60
Locations
1
Primary Endpoint
Change in Disability of the Arm, Shoulder and Hand score (DASH)
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Arms & Interventions

Partial denervation of the wrist joint

Experimental

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

Intervention: Partial denervation of the wrist joint (Procedure)

Outcomes

Primary Outcomes

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

Time Frame: peroperatively, 3, 6 and 12 months postoperatively

questionnaire

Secondary Outcomes

  • 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 EQ5D(peroperatively, 3, 6 and 12 months postoperatively)
  • Change in Sence Of Coherence -13 (SOC13)(peroperatively, 3, 6 and 12 months postoperatively)
  • Change in Patient Related Wrist Evaluation (PRWE)(peroperatively, 3, 6 and 12 months postoperatively)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Elin Swärd

MD, Principal Investigator

Karolinska Institutet

Study Sites (1)

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