NCT06098586

Brief Summary

A randomized controlled trial comparing partial wrist denervation to a self-managed exercise therapy program in 140 patients with wrist osteoarthritis.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P50-P75 for not_applicable

Timeline
19mo left

Started Nov 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress62%
Nov 2023Nov 2027

First Submitted

Initial submission to the registry

October 18, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 24, 2023

Completed
22 days until next milestone

Study Start

First participant enrolled

November 15, 2023

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2027

Last Updated

February 21, 2025

Status Verified

November 1, 2024

Enrollment Period

3 years

First QC Date

October 18, 2023

Last Update Submit

February 19, 2025

Conditions

Osteoarthritis Wrist

Outcome Measures

Primary Outcomes (1)

  • PRWE

    Patient Rated Wrist Evaluation (PRWE) score (0-100 (high score worse outcome)) (MacDermid et al., 1998)

    6 months

Secondary Outcomes (37)

  • PRWE

    3 months

  • PRWE

    12 months

  • PRWE

    5 years

  • Pain NRS

    3 months

  • Pain NRS

    6 months

  • +32 more secondary outcomes

Study Arms (2)

Self-managed exercise therapy program

ACTIVE COMPARATOR

Exercise program focusing on functional re-learning and strengthening of the musculoskeletal system with the aim to create a stable wrist that can be used in a pain-free manner in activities of daily living.

Behavioral: Self-managed exercise therapy program

Partial wrist denervation

ACTIVE COMPARATOR

AIN and PIN neurectomy through a dorsal approach as described by Berger (Berger, 1998).

Procedure: Partial wrist denervation

Interventions

Self-managed exercise therapy programBEHAVIORAL

Exercise program focusing on functional re-learning and strengthening of the musculoskeletal system with the aim to create a stable wrist that can be used in a pain-free manner in activities of daily living.

Self-managed exercise therapy program
Partial wrist denervationPROCEDURE

AIN and PIN neurectomy through a dorsal approach as described by Berger (Berger, 1998).

Partial wrist denervation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥ 18 years.
  • Chronic wrist pain (≥6 months) due to Scapholunate advanced collapse (SLAC) / Scaphoid non-union advanced collapse (SNAC) grade 1-3 osteoarthritis.
  • Radiological signs of osteoarthritis on posteroanterior and lateral radiograph.

You may not qualify if:

  • Previous PIN or AIN neurectomy.
  • Rheumatoid arthritis or other chronic inflammatory arthritis.
  • Symptomatic osteoarthritis in the distal radio-ulnar (DRU), Scapho-trapezio-trapezoid (STT) or thumb carpometacarpal (CMC) joints.
  • Ongoing infection.
  • Inability to co-operate with the follow-up protocol.
  • Systemic or intra-articular glucocorticoids or intraarticular PRP or Hyaluronic acid injections in the affected joint within 3 months prior to enrollment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Department of hand surgery, Malmo university hospital

Malmo, 20502, Sweden

RECRUITING

Department of hand handsurgery, Södersjukhuset

Stockholm, 11883, Sweden

RECRUITING

Related Publications (1)

  • Larsson SL, Tandrup T, Brogren E, Wilcke MK, Sward EM. Partial wrist denervation versus patient education and self-managed exercise therapy in patients with wrist osteoarthritis: study protocol for a randomized controlled trial. Trials. 2025 Oct 30;26(1):453. doi: 10.1186/s13063-025-09241-7.

    PMID: 41168861DERIVED

Study Officials

  • Elin Swärd, MD, PhD

    Karolinska Institutet

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Elin Swärd, MD, PhD

CONTACT

+4612360000elin.sward@regionstockholm.se

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Data assessors and analysts will be masked for treatment allocation (covered wrist / anonymous data sheet).
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 18, 2023

First Posted

October 24, 2023

Study Start

November 15, 2023

Primary Completion (Estimated)

November 15, 2026

Study Completion (Estimated)

November 15, 2027

Last Updated

February 21, 2025

Record last verified: 2024-11

Locations

SE(2)