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NCT Number: NCT03378362

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.

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Key information

Conditions

Wrist Arthritis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Handkirurgiska kliniken Södersjukhuset

Stockholm, 11883, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Partial denervation of the wrist joint

Procedure

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

Primary outcomes

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

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

    questionnaire

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Dec 19, 2017
Registry last updated
Mar 31, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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