Denervation for Osteoarthritis in the PIP-joint Efficacy Study (DOPS)
NCT ID: NCT05980793
Last Updated: 2024-12-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
90 participants
INTERVENTIONAL
2023-09-25
2029-07-15
Brief Summary
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* 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
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Surgical treatment
PIP joint denervation is performed through a volar approach.
PIP joint denervation
Surgical denervation of the PIP joint
Non-surgical treatment
An education and exercise program.
Patient education plus exercise
An education plus exercise program
Interventions
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PIP joint denervation
Surgical denervation of the PIP joint
Patient education plus exercise
An education plus exercise program
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Stockholm South General Hospital
OTHER
Karolinska Institutet
OTHER
Responsible Party
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Elin Swärd
MD, PhD
Principal Investigators
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Elin Sward, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Department of Hand Surgery Sodersjukhuset and Karolinska Institutet
Locations
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Department of Hand Surgery, Södersjukhuset
Stockholm, , Sweden
Countries
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Central Contacts
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Facility Contacts
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Elin Swärd, MD, PhD
Role: primary
References
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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.
Other Identifiers
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DOPS
Identifier Type: -
Identifier Source: org_study_id