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

Karolinska Institute

Status: Enrolling

Conditions: Osteoarthritis Finger; Surgery

Treatments: Procedure: PIP joint denervation; Procedure: Patient education plus exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT05980793

DOPS

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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90 participants in 2 patient groups

Surgical treatment

Active Comparator group

Description:

PIP joint denervation is performed through a volar approach.

Treatment:

Procedure: PIP joint denervation

Non-surgical treatment

Active Comparator group

Description:

An education and exercise program.

Treatment:

Procedure: Patient education plus exercise