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

Primary Purpose

Osteoarthritis Finger, Surgery

Status
Recruiting
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
PIP joint denervation
Patient education plus exercise
Sponsored by
Karolinska Institutet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis Finger

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Department of Hand Surgery, SödersjukhusetRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Surgical treatment

Non-surgical treatment

Arm Description

PIP joint denervation is performed through a volar approach.

An education and exercise program.

Outcomes

Primary Outcome Measures

Pain on load (change baseline to -12 months)
Pain (Numerical Rating Scale, 0-100 points, 100 is a worse outcome)

Secondary Outcome Measures

Pain at rest (change baseline to -3, -6, -12 months)
Pain (Numerical Rating Scale, 0-100 points, 100 is a worse outcome)
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.
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)
EQ5D-5L change baseline to -3, -6, -12 months
A questionnaire that measures quality of life (0-1 point, 0 is a worse outcome).
Objective function change baseline to -3, -6, -12 months
Range of motion (goniometer with 5 degrees interval)
Objective function change baseline to -3, -6, -12 months
grip strength (hydraulic hand dynamometer, kilograms)
Complications
2PD (Two point discrimination, 0-15mm, 15 indicating a worse outcome)
Complications
Mini Sollerman (0-12 points, 12 indicating a better outcome)
Complications
Infection (clinical evaluation, positive cultures, need for antibiotics)
Additional treatment
Need for further surgery/treatment

Full Information

First Posted
June 29, 2023
Last Updated
October 16, 2023
Sponsor
Karolinska Institutet
Collaborators
Stockholm South General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05980793
Brief Title
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

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 25, 2023 (Actual)
Primary Completion Date
July 15, 2028 (Anticipated)
Study Completion Date
July 15, 2029 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet
Collaborators
Stockholm South General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis Finger, Surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A parallel group, two-arm, randomized, controlled trial.
Masking
Outcomes Assessor
Masking Description
Data analysts will be masked for treatment allocation
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Surgical treatment
Arm Type
Active Comparator
Arm Description
PIP joint denervation is performed through a volar approach.
Arm Title
Non-surgical treatment
Arm Type
Active Comparator
Arm Description
An education and exercise program.
Intervention Type
Procedure
Intervention Name(s)
PIP joint denervation
Intervention Description
Surgical denervation of the PIP joint
Intervention Type
Procedure
Intervention Name(s)
Patient education plus exercise
Intervention Description
An education plus exercise program
Primary Outcome Measure Information:
Title
Pain on load (change baseline to -12 months)
Description
Pain (Numerical Rating Scale, 0-100 points, 100 is a worse outcome)
Time Frame
0-12 months
Secondary Outcome Measure Information:
Title
Pain at rest (change baseline to -3, -6, -12 months)
Description
Pain (Numerical Rating Scale, 0-100 points, 100 is a worse outcome)
Time Frame
0-12 months
Title
HQ8 (8-item patient questionnaire) change baseline to -3, -6, 12 months
Description
A questionnaire used by Swedish Healthcare Quality Registry for hand surgery (HAKIR), 0-100 points, 100 is a worse outcome.
Time Frame
0-12 months
Title
PRWHE (Patient Rated Wrist/Hand Evaluation) change baseline to -3, 6, 12 months
Description
A questionnaire that measures hand/wrist function (0-100 points, 100 is a worse outcome)
Time Frame
0-12 months
Title
EQ5D-5L change baseline to -3, -6, -12 months
Description
A questionnaire that measures quality of life (0-1 point, 0 is a worse outcome).
Time Frame
0-12 months
Title
Objective function change baseline to -3, -6, -12 months
Description
Range of motion (goniometer with 5 degrees interval)
Time Frame
0-12 months
Title
Objective function change baseline to -3, -6, -12 months
Description
grip strength (hydraulic hand dynamometer, kilograms)
Time Frame
0-12 months
Title
Complications
Description
2PD (Two point discrimination, 0-15mm, 15 indicating a worse outcome)
Time Frame
0-12 months
Title
Complications
Description
Mini Sollerman (0-12 points, 12 indicating a better outcome)
Time Frame
0-12 months
Title
Complications
Description
Infection (clinical evaluation, positive cultures, need for antibiotics)
Time Frame
0-12 months
Title
Additional treatment
Description
Need for further surgery/treatment
Time Frame
0-12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Elin Sward, MD, PhD
Phone
+46812361000
Email
elin.sward@regionstockholm.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elin Sward, MD, PhD
Organizational Affiliation
Department of Hand Surgery Sodersjukhuset and Karolinska Institutet
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Hand Surgery, Södersjukhuset
City
Stockholm
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elin Swärd, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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

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