Denervation for Osteoarthritis in the PIP-joint Efficacy... | NCT05980793

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

NCT05980793

Sponsor

Karolinska Institutet

Status

Recruiting

Last Update Posted

Dec 2, 2024Actual

Enrollment

90Estimated

Phase

Not Applicable

Conditions

Osteoarthritis Finger
Surgery

Interventions

PIP joint denervation
Patient education plus exercise

Countries

Sweden

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 25, 2023Actual

Primary Completion Date

Jul 15, 2028Estimated

Completion Date

Jul 15, 2029Estimated

First Submitted Date

Jun 29, 2023

First Submission Date that Met QC Criteria

Jul 31, 2023

First Posted Date

Aug 8, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 27, 2024

Last Update Posted Date

Dec 2, 2024Actual

Name	Class
Stockholm South General Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

90Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Surgical treatment	Active Comparator	PIP joint denervation is performed through a volar approach.	Procedure: PIP joint denervation
Non-surgical treatment	Active Comparator	An education and exercise program.	Procedure: Patient education plus exercise

Interventions

Name	Type	Description	Arm Group Labels	Other Names
PIP joint denervation	Procedure	Surgical denervation of the PIP joint	Surgical treatment

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Elin Sward, MD, PhD	Contact	+46812361000		elin.sward@regionstockholm.se

Overall Officials

Name	Affiliation	Role
Elin Sward, MD, PhD	Department of Hand Surgery Sodersjukhuset and Karolinska Institutet	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Hand Surgery, Södersjukhuset	Recruiting	Stockholm			Sweden

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
39169395	Derived	Sward EM, Beckman J, Tabaroj F, Wilcke MK. Efficacy of denervation for osteoarthritis in the proximal interphalangeal joint (DOP): protocol of a randomized controlled trial. Trials. 2024 Aug 22;25(1):553. doi: 10.1186/s13063-024-08399-w.

ID	Term
D010353	Patient Education as Topic
D015444	Exercise

ID	Term
D006266	Health Education
D011314	Preventive Health Services
D006296	Health Services
D005159	Health Care Facilities Workforce and Services