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Recruiting NCT05980793

Denervation for Osteoarthritis in the PIP-joint Efficacy Study (DOPS)

No phase Interventional Osteoarthritis Finger Surgery

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: PIP joint denervation, Patient education plus exercise.
Who it may be relevant to
Registry conditions: Osteoarthritis Finger, Surgery. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Sweden
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Denervation for Osteoarthritis in the PIP-joint Efficacy Study (DOPS), a Randomized Controlled Trial

Overview

The goal of this clinical trial is to compare the effects of a surgical and a non-surgical treatment method in patients with osteoarthritis in the proximal interphalangeal (PIP) joint. The main questions it aims to answer are: * Are the treatments effective? * Is the surgical treatment more effective than the non-surgical treatment? Participants will receive surgical treatment (PIP joint denervation) or non surgical treatment (patient education plus exercise). Researchers will compare the non-surgical and surgical groups to see if pain, patient-reported function, quality of life, movement and grip strength differs between the groups.

Detailed description

This is a parallel group, two-arm, randomized, controlled trial comparing the effects of surgical denevation to patient education plus exercise in patients with symptomatic PIP joint osteoarthritis.

The research questions are:

1. Does any of the treatments denervation of the PIP-joint and patient education plus exercise decrease pain, improve patient-reported outcomes, grip strength and range of motion (ROM) in PIP-joint osteoarthritis? 2. Does denervation of the PIP-joint decrease pain, and improve patient-reported outcomes grip strength and ROM more effectively than patient education plus exercise for PIP-joint osteoarthritis?

Participants will be randomly assigned (1:1) to receive surgical denervation of the PIP-joint or education plus exercise. A block randomization scheme with a fixed block size of 10 will be used. Patients will be stratified according to gender. Sealed opaque envelopes will be used and data analysts will be masked for treatment allocation.

Assesments will be made at inclusion, and after 3, 6 and 12 months. The studys primary enpoint is 12 months after intervention.

Interventions

  • Procedure PIP joint denervation
    Surgical denervation of the PIP joint
  • Procedure Patient education plus exercise
    An education plus exercise program

Primary outcome measures

  • Pain on load (change baseline to -12 months) [Time frame: 0-12 months]
Secondary outcome measures (10)
  • Pain at rest (change baseline to -3, -6, -12 months) [Time frame: 0-12 months]
  • HQ8 (8-item patient questionnaire) change baseline to -3, -6, 12 months [Time frame: 0-12 months]
  • PRWHE (Patient Rated Wrist/Hand Evaluation) change baseline to -3, 6, 12 months [Time frame: 0-12 months]
  • EQ5D-5L change baseline to -3, -6, -12 months [Time frame: 0-12 months]
  • Objective function change baseline to -3, -6, -12 months [Time frame: 0-12 months]
  • Objective function change baseline to -3, -6, -12 months [Time frame: 0-12 months]
  • Complications [Time frame: 0-12 months]
  • Complications [Time frame: 0-12 months]
  • Complications [Time frame: 0-12 months]
  • Additional treatment [Time frame: 0-12 months]

Eligibility criteria

Inclusion criteria

  • Age ≥ 18 years.
  • Chronic symptomatic osteoarthritis in the PIP-joint.
  • Radiological signs of osteoarthritis on posteroanterior and lateral radiographs assessed by the Kellgren-Lawrence classification (grade II-IV) (Kellgren \& Lawrence, 1957).
  • Clinical signs of PIP-joint arthritis.

Exclusion criteria

  • Inflammatory arthritis.
  • Ongoing infection in the hand.
  • Inability to co-operate with the follow-up protocol.
  • Intra-articular glucocorticoid, PRP or Hyaluronic acid injections in the affected joint less than 3 months prior to enrollment.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Sweden · 1 center
  • Department of Hand Surgery, Södersjukhuset — Stockholm

Publications

  • Sward EM, Beckman J, Tabaroj F, Wilcke MK. Efficacy of denervation for osteoarthritis in the proximal interphalangeal joint (DOP): protocol of a randomized controlled trial. Trials. 2024 Aug 22;25(1):553. doi: 10.1186/s13063-024-08399-w. PMID 39169395

Identifiers

NCT: NCT05980793 · DOPS

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗