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

Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05980793
• Other study ID #: DOPS
• Status: Recruiting
• Phase: N/A
• Start date: September 25, 2023
• Est. completion date: July 15, 2029

Study information

• Verified date: October 2023
• Source: Karolinska Institutet
• Contact: Elin Sward, MD, PhD
• Phone: +46812361000
• Email: elin.sward[@]regionstockholm.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: July 15, 2029
• Est. primary completion date: July 15, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis Finger
• Surgery

Intervention

Procedure:
• PIP joint denervation
Surgical denervation of the PIP joint
• Patient education plus exercise
An education plus exercise program

Locations

Country	Name	City	State
Sweden	Department of Hand Surgery, Södersjukhuset	Stockholm

Sponsors (2)

Lead Sponsor	Collaborator
Karolinska Institutet	Stockholm South General Hospital

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain on load (change baseline to -12 months)	Pain (Numerical Rating Scale, 0-100 points, 100 is a worse outcome)	0-12 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Objective function change baseline to -3, -6, -12 months	Range of motion (goniometer with 5 degrees interval)	0-12 months
Secondary	Objective function change baseline to -3, -6, -12 months	grip strength (hydraulic hand dynamometer, kilograms)	0-12 months
Secondary	Complications	2PD (Two point discrimination, 0-15mm, 15 indicating a worse outcome)	0-12 months
Secondary	Complications	Mini Sollerman (0-12 points, 12 indicating a better outcome)	0-12 months
Secondary	Complications	Infection (clinical evaluation, positive cultures, need for antibiotics)	0-12 months
Secondary	Additional treatment	Need for further surgery/treatment	0-12 months