Health TrialsbyHealthPanel

Proximal Row Carpectomy vs Four-corner Fusion for Osteoarthritis of the Wrist

ConditionsWrist OsteoarthritisScapholunate Advanced Collapse
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorTöölö Hospital

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

SLAC/SNAC II-III

Age 18 - 75

Symptom duration > 3 months

American Society of Anaesthesiologists physical status (ASA) I-II

Disqualifiers

Patient eligible for SL reconstruction or scaphoid

Ulnocarpal/pancarpal arthritis

Lunate fossa, proximal lunate arthrosis or both

Age <18 or >75 years

Trial design

Design model

Parallel

Treatments tested in this trial

  • Proximal Row Carpectomy

    Procedure/Surgery

    Excision of the proximal carpal row - the scaphoid, lunate and triquetrum

  • Four-corner fusion

    Procedure/Surgery

    Scaphoid excision and four-corner fusion with cannulated headless compression screws/dorsal plate

Treatment groups

84 Participants
are divided into 2 treatment groups
Group A: Proximal Row CarpectomyExperimental treatment 1 intervention
Group B: Four-corner fusionActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Patient-Rated Wrist Evaluation

The PRWE comprises 15 questions to measure wrist pain and disability in daily activities. In PRWE patients rate wrist pain and disability from 0 to 10 and it consists two subscales: Pain and Function (0=best possible outcome, 10=worst possible outcome)

Time frame
12 months

Secondary outcomes

1

Quick-Disabilities of the Arm, Shoulder and Hand

The QuickDASH is self-reported questionnaire and shortened version of DASH outcome measure to measure physical function and symptoms in people with any or multiple musculoskeletal disorders of the upper limb in 11 dimensions in 1-5 scale (1=best possible outcome, 5=worst possible outcome)

Time frame
12 months
2

Pain (Visual Analogue Scale)

The VAS is derived by health care professional question of pain in scale 0 to 10 (0=no pain, 10=worst possible pain)

Time frame
12 months
3

Global improvement

Global rating to treatment effect will be evaluated by question: "How would you rate the function of your hand compared to the situation before the treatment?". The options are in 5-step Likert scale from (-2) Much worse to (+2) Much better

Time frame
12 months
4

Grip strength

Grip strength is measured with a dynamometer in kg as the mean of three measurements. It will be numbered in kg and percentage of the unaffected side

Time frame
12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Töölö Hospital

Lead sponsor

Tampere University Hospital

Collaborator

Turku University Hospital

Collaborator

Jyväskylä Central Hospital

Collaborator

Kymenlaakso Central Hospital Kotka Finland

Collaborator

Source ClinicalTrials.gov
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