NCT04260165

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at P50-P75 for not_applicable

Timeline
105mo left

Started Oct 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

5 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress39%
Oct 2020Dec 2034

First Submitted

Initial submission to the registry

February 5, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 7, 2020

Completed
8 months until next milestone

Study Start

First participant enrolled

October 1, 2020

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
10 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2034

Expected
Last Updated

January 19, 2021

Status Verified

January 1, 2021

Enrollment Period

4.3 years

First QC Date

February 5, 2020

Last Update Submit

January 14, 2021

Conditions

Wrist OsteoarthritisScapholunate Advanced Collapse

Keywords

Wrist OsteoarthritisScapholunate Advanced CollapseScaphoid Non-union Advanced CollapseWrist arthrodesisProximal Row Carpectomy

Outcome Measures

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)

    12 months

Secondary Outcomes (8)

  • Quick-Disabilities of the Arm, Shoulder and Hand

    12 months

  • Pain (Visual Analogue Scale)

    12 months

  • Global improvement

    12 months

  • Grip strength

    12 months

  • Wrist range of motion (ROM)

    12 months

  • +3 more secondary outcomes

Study Arms (2)

Proximal Row Carpectomy

EXPERIMENTAL
Procedure: Proximal Row Carpectomy

Four-corner fusion

ACTIVE COMPARATOR
Procedure: Four-corner fusion

Interventions

Proximal Row CarpectomyPROCEDURE

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

Proximal Row Carpectomy
Four-corner fusionPROCEDURE

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

Four-corner fusion

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Töölö Hospital (Helsinki University Hospital)

Helsinki, Finland

RECRUITING

Central Hospital of Central Finland

Jyväskylä, Finland

NOT YET RECRUITING

Kymenlaakso Central Hospital

Kotka, Finland

NOT YET RECRUITING

Tampere University Hospital

Tampere, Finland

NOT YET RECRUITING

Turku University Hospital

Turku, Finland

NOT YET RECRUITING

Related Publications (1)

  • Alanen M, Stjernberg-Salmela S, Waris E, Karjalainen T, Miettunen J, Ryhanen J, Aspinen S. Proximal ROw carpectOmy versus four-corner Fusion (PROOF-trial) for osteoarthritis of the wrist: study protocol for multi-institutional double-blinded randomized controlled trial. Trials. 2023 Aug 7;24(1):499. doi: 10.1186/s13063-023-07544-1.

    PMID: 37550711DERIVED

Central Study Contacts

Samuli Aspinen, MD, PhD

CONTACT

+358406360546samuli.aspinen@hus.fi

Jorma Ryhänen, adj. prof.

CONTACT

jorma.ryhanen@hus.fi

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

February 5, 2020

First Posted

February 7, 2020

Study Start

October 1, 2020

Primary Completion

December 31, 2024

Study Completion (Estimated)

December 31, 2034

Last Updated

January 19, 2021

Record last verified: 2021-01

Locations

FI(5)