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

Study Overview
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Brief Summary
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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
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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: 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? 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.

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

Conditions
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Osteoarthritis Finger, Surgery

Intervention / Treatment
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* Procedure: PIP joint denervation
* Procedure: Patient education plus exercise


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A parallel group, two-arm, randomized, controlled trial.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Surgical treatment<br>PIP joint denervation is performed through a volar approach. | Procedure: PIP joint denervation<br>* Surgical denervation of the PIP joint<br>|
| Active Comparator: Non-surgical treatment<br>An education and exercise program. | Procedure: Patient education plus exercise<br>* An education plus exercise program<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain on load (change baseline to -12 months) | Pain (Numerical Rating Scale, 0-100 points, 100 is a worse outcome) | 0-12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain at rest (change baseline to -3, -6, -12 months) | Pain (Numerical Rating Scale, 0-100 points, 100 is a worse outcome) | 0-12 months | 
| HQ8 (8-item patient questionnaire) change baseline to -3, -6, 12 months | A questionnaire used by Swedish Healthcare Quality Registry for hand surgery (HAKIR), 0-100 points, 100 is a worse outcome. | 0-12 months | 
| PRWHE (Patient Rated Wrist/Hand Evaluation) change baseline to -3, 6, 12 months | A questionnaire that measures hand/wrist function (0-100 points, 100 is a worse outcome) | 0-12 months | 
| EQ5D-5L change baseline to -3, -6, -12 months | A questionnaire that measures quality of life (0-1 point, 0 is a worse outcome). | 0-12 months | 
| Objective function change baseline to -3, -6, -12 months | Range of motion (goniometer with 5 degrees interval) | 0-12 months | 
| Objective function change baseline to -3, -6, -12 months | grip strength (hydraulic hand dynamometer, kilograms) | 0-12 months | 
| Complications | 2PD (Two point discrimination, 0-15mm, 15 indicating a worse outcome) | 0-12 months | 
| Complications | Mini Sollerman (0-12 points, 12 indicating a better outcome) | 0-12 months | 
| Complications | Infection (clinical evaluation, positive cultures, need for antibiotics) | 0-12 months | 
| Additional treatment | Need for further surgery/treatment | 0-12 months |