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

NCT05980793 | Recruiting

• 1 other identifier: DOPS
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis Finger; Surgery

Outcome Measures

Primary Outcomes (1)

• 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 (10)

• Pain at rest (change baseline to -3, -6, -12 months)

  0-12 months

• HQ8 (8-item patient questionnaire) change baseline to -3, -6, 12 months

  0-12 months

• PRWHE (Patient Rated Wrist/Hand Evaluation) change baseline to -3, 6, 12 months

  0-12 months

• EQ5D-5L change baseline to -3, -6, -12 months

  0-12 months

• Objective function change baseline to -3, -6, -12 months

  0-12 months

Study Arms (2)

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

PIP joint denervation PROCEDURE

Surgical denervation of the PIP joint

Surgical treatment

Patient education plus exercise PROCEDURE

An education plus exercise program

Non-surgical treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Karolinska Institutet: lead
• Stockholm South General Hospital: collaborator

Study Sites (1)

Department of Hand Surgery, Södersjukhuset

Stockholm, Sweden

RECRUITING

Related Publications (1)

• 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.

  PMID: 39169395 DERIVED

MeSH Terms

Interventions

Patient Education as Topic; Exercise

Intervention Hierarchy (Ancestors)

Health Education; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Elin Sward, MD, PhD

  Department of Hand Surgery Sodersjukhuset and Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elin Sward, MD, PhD

CONTACT

+46812361000; elin.sward@regionstockholm.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Data analysts will be masked for treatment allocation
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Model Details: A parallel group, two-arm, randomized, controlled trial.

Study Record Dates

• First Submitted: June 29, 2023
• First Posted: August 8, 2023
• Study Start: September 25, 2023
• Primary Completion (Estimated): July 15, 2028
• Study Completion (Estimated): July 15, 2029
• Last Updated: December 2, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)