Clinical trial NCT04260165: Proximal Row Carpectomy vs Four-corner Fusion for Osteoarthritis of the Wrist
Official title: A Double-blinded Randomized Controlled Multicenter Trial Comparing Proximal ROw carpectOmy and Four-corner Fusion (PROOF) for Osteoarthritis of the Wrist
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Wrist Osteoarthritis
Scapholunate Advanced Collapse
Keywords: Wrist Osteoarthritis
Scapholunate Advanced Collapse
Scaphoid Non-union Advanced Collapse
Wrist arthrodesis
Proximal Row Carpectomy
Lead sponsor: Töölö Hospital
Sponsor class: OTHER
Collaborators: name: Tampere University Hospital
name: Turku University Hospital
name: Jyväskylä Central Hospital
name: Kymenlaakso Central Hospital Kotka Finland
First posted: 2020-02-07
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Study purpose is to compare the outcome after proximal row carpectomy (PRC) vs four-corner fusion (FCA) for SLAC/SNAC II-III type osteoarthritis (OA) in a double-blinded randomized controlled study setting.

Patients with radiologically and clinically confirmed OA are randomized (1:1 computer generated sequence with random block size) to two parallel groups and will undergo either PRC or FCA. The study will be patient and assessor blinded.

Baseline data is collected preoperatively and is followed by a follow-up visits at 2 and 6 weeks, 3, 6, 12 months, and 5, 10 years after the intervention. Unveiling of the allocation is at 12 months post-intervention.


Eligibility criteria: Inclusion Criteria:

* SLAC/SNAC II-III
* Age 18 - 75
* Symptom duration \> 3 months
* American Society of Anaesthesiologists physical status (ASA) I-II

Exclusion Criteria:

* Patient eligible for SL reconstruction or scaphoid
* Ulnocarpal/pancarpal arthritis
* Lunate fossa, proximal lunate arthrosis or both
* Age \<18 or \>75 years
* Rheumatoid arthritis
* Heavy smoking (\> 20 cigarettes per day)
* Condition or medication affecting bony healing (eg diabetes mellitus with poor glycemic control, malnutrition, use of per oral corticosteroids)
* Alcohol or drug abuse
* Neurological condition affecting upper limb function

Primary outcomes:
measure: Patient-Rated Wrist Evaluation
timeFrame: 12 months
Secondary outcomes:
measure: Quick-Disabilities of the Arm, Shoulder and Hand
timeFrame: 12 months
measure: Pain (Visual Analogue Scale)
timeFrame: 12 months
measure: Global improvement
timeFrame: 12 months
measure: Grip strength
timeFrame: 12 months
measure: Wrist range of motion (ROM)
timeFrame: 12 months
measure: Complications
timeFrame: 12 months
measure: Patient-rated Quality of Life (EQ-5D)
timeFrame: 12 months
measure: Cost-effectiveness
timeFrame: 12 months
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Töölö Hospital (Helsinki University Hospital)
city: Jyväskylä
country: Finland
facility: Central Hospital of Central Finland
city: Kotka
country: Finland
facility: Kymenlaakso Central Hospital
city: Tampere
country: Finland
facility: Tampere University Hospital
city: Turku
country: Finland
facility: Turku University Hospital
Study officials:
References: