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Pain Relief and Functional Outcome After Partial Denervation of the Wrist

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ClinicalTrials.gov Identifier: NCT03378362
Recruitment Status : Recruiting
First Posted : December 19, 2017
Last Update Posted : March 3, 2021
Sponsor:
Information provided by (Responsible Party):
Elin Swärd, Karolinska Institutet

Study Description
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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.

Condition or disease Intervention/treatment Phase
Wrist Arthritis Procedure: Partial denervation of the wrist joint Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective Study on Pain Relief and Functional Outcome After Partial Denervation of the Wrist
Actual Study Start Date : December 31, 2017
Estimated Primary Completion Date : August 31, 2021
Estimated Study Completion Date : August 31, 2021
Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Change in Disability of the Arm, Shoulder and Hand score (DASH) [ Time Frame: peroperatively, 3, 6 and 12 months postoperatively ]
    questionnaire


Secondary Outcome Measures :
  1. Change in Patient Related Wrist Evaluation (PRWE) [ Time Frame: peroperatively, 3, 6 and 12 months postoperatively ]
    questionnaire

  2. Change in EQ5D [ Time Frame: peroperatively, 3, 6 and 12 months postoperatively ]
    questionnaire

  3. Change in Hospital Anxiety and Depression Scale (HADS) [ Time Frame: peroperatively, 3, 6 and 12 months postoperatively ]
    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.

  4. Change in range of motion, grip strength [ Time Frame: peroperatively, 3, 6 and 12 months postoperatively ]
    objective physical function

  5. Change in Sence Of Coherence -13 (SOC13) [ Time Frame: peroperatively, 3, 6 and 12 months postoperatively ]
    Questionnaire


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03378362


Contacts
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Contact: Elin Sward, MD +46704820372 elin.sward@sll.se
Contact: Maria Wilcke, MD, PhD

Locations
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Sweden
Handkirurgiska kliniken Södersjukhuset Recruiting
Stockholm, Sweden, 11883
Contact: Elin M Swärd, Md    +46704820372    Elin.sward@sll.se   
Contact: Maria Wilcke    +46708294613    Maria.wilcke@sll.se   
Sponsors and Collaborators
Karolinska Institutet
Investigators
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Study Director: Maria Wilcke, MD, PhD Karolinska Institutet
More Information
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Responsible Party: Elin Swärd, MD, Principal Investigator, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT03378362    
Other Study ID Numbers: Karolinska Institute
First Posted: December 19, 2017    Key Record Dates
Last Update Posted: March 3, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Arthritis
Joint Diseases
Musculoskeletal Diseases