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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Surgery; Osteoarthritis Finger
• Intervention / Treatment: Procedure: PIP joint denervation; Procedure: Patient education plus exercise

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.

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Elin Sward, MD, PhD; Phone Number: +46812361000; Email: elin.sward@regionstockholm.se

Study Locations

• Sweden
  • Stockholm, Sweden
    • Recruiting
    • Department of Hand Surgery, Södersjukhuset
    • Contact: Elin Swärd, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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
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
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

Collaborators and Investigators

• Sponsor: Karolinska Institutet
• Collaborators: Stockholm South General Hospital
• Investigators: Principal Investigator: Elin Sward, MD, PhD, Department of Hand Surgery Sodersjukhuset and Karolinska Institutet

Study record dates

Study Major Dates

• Study Start (Actual): September 25, 2023
• Primary Completion (Estimated): July 15, 2028
• Study Completion (Estimated): July 15, 2029

Study Registration Dates

• First Submitted: June 29, 2023
• First Submitted That Met QC Criteria: July 31, 2023
• First Posted (Actual): August 8, 2023

Study Record Updates

• Last Update Posted (Estimated): December 2, 2024
• Last Update Submitted That Met QC Criteria: November 27, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Osteoarthritis
• Other Study ID Numbers: DOPS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No