Clinical trial NCT05980793: Denervation for Osteoarthritis in the PIP-joint Efficacy Study (DOPS)
Official title: Denervation for Osteoarthritis in the PIP-joint Efficacy Study (DOPS), a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Osteoarthritis Finger
Surgery
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Stockholm South General Hospital
First posted: 2023-08-08
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A parallel group, two-arm, randomized, controlled trial.
Primary purpose: TREATMENT

Brief summary: 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.

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.

Primary outcomes:
measure: Pain on load (change baseline to -12 months)
timeFrame: 0-12 months
Secondary outcomes:
measure: Pain at rest (change baseline to -3, -6, -12 months)
timeFrame: 0-12 months
measure: HQ8 (8-item patient questionnaire) change baseline to -3, -6, 12 months
timeFrame: 0-12 months
measure: PRWHE (Patient Rated Wrist/Hand Evaluation) change baseline to -3, 6, 12 months
timeFrame: 0-12 months
measure: EQ5D-5L change baseline to -3, -6, -12 months
timeFrame: 0-12 months
measure: Objective function change baseline to -3, -6, -12 months
timeFrame: 0-12 months
measure: Objective function change baseline to -3, -6, -12 months
timeFrame: 0-12 months
measure: Complications
timeFrame: 0-12 months
measure: Complications
timeFrame: 0-12 months
measure: Complications
timeFrame: 0-12 months
measure: Additional treatment
timeFrame: 0-12 months
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Department of Hand Surgery, Södersjukhuset
Study officials:
affiliation: Department of Hand Surgery Sodersjukhuset and Karolinska Institutet
name: Elin Sward, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: