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

Primary Purpose

Wrist Osteoarthritis, Scapholunate Advanced Collapse

Status

Recruiting

Phase

Not Applicable

Locations

Finland

Study Type

Interventional

Intervention

Proximal Row Carpectomy

Four-corner fusion

About this trial

This is an interventional treatment trial for Wrist Osteoarthritis focused on measuring Wrist Osteoarthritis, Scapholunate Advanced Collapse, Scaphoid Non-union Advanced Collapse, Wrist arthrodesis, Proximal Row Carpectomy

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Töölö Hospital (Helsinki University Hospital)Recruiting
Central Hospital of Central Finland
Kymenlaakso Central Hospital
Tampere University Hospital
Turku University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Proximal Row Carpectomy

Four-corner fusion

Arm Description

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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)

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)

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

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

Wrist range of motion (ROM)

Wrist ROM is measured on both wrists with a handheld goniometer in degrees.

Complications

Incidence of complications (i.e. non-union, fracture, reoperation, infection, hematoma, iatrogenic tendon/nerve/arterial injury, complex regional pain syndrome) is recorded and compared between study groups.

Patient-rated Quality of Life (EQ-5D)

Cost-effectiveness

Quality-adjusted life years/months measured as a change in EQ-5D

Full Information

NCT ID

NCT04260165

First Posted

February 5, 2020

Last Updated

January 14, 2021

Sponsor

Töölö Hospital

Collaborators

Tampere University Hospital, Turku University Hospital, Jyväskylä Central Hospital, Kymenlaakso Central Hospital Kotka Finland

1. Study Identification

Unique Protocol Identification Number

NCT04260165

Brief Title

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

Acronym

PROOF

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

2. Study Status

Record Verification Date

January 2021

Overall Recruitment Status

Recruiting

Study Start Date

October 1, 2020 (Actual)

Primary Completion Date

December 31, 2024 (Anticipated)

Study Completion Date

December 31, 2034 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Töölö Hospital

Collaborators

Tampere University Hospital, Turku University Hospital, Jyväskylä Central Hospital, Kymenlaakso Central Hospital Kotka Finland

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Wrist Osteoarthritis, Scapholunate Advanced Collapse

Keywords

Wrist Osteoarthritis, Scapholunate Advanced Collapse, Scaphoid Non-union Advanced Collapse, Wrist arthrodesis, Proximal Row Carpectomy

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

84 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Proximal Row Carpectomy

Arm Type

Experimental

Arm Title

Four-corner fusion

Arm Type

Active Comparator

Intervention Type

Procedure

Intervention Name(s)

Proximal Row Carpectomy

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

Four-corner fusion

Intervention Description

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

Primary Outcome Measure Information:

Title

Patient-Rated Wrist Evaluation

Description

Time Frame

12 months

Secondary Outcome Measure Information:

Title

Quick-Disabilities of the Arm, Shoulder and Hand

Description

Time Frame

12 months

Title

Pain (Visual Analogue Scale)

Description

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

Title

Global improvement

Description

Time Frame

12 months

Title

Grip strength

Description

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

Title

Wrist range of motion (ROM)

Description

Wrist ROM is measured on both wrists with a handheld goniometer in degrees.

Time Frame

12 months

Title

Complications

Description

Time Frame

12 months

Title

Patient-rated Quality of Life (EQ-5D)

Time Frame

12 months

Title

Cost-effectiveness

Description

Quality-adjusted life years/months measured as a change in EQ-5D

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Samuli Aspinen, MD, PhD

Phone

+358406360546

samuli.aspinen@hus.fi

First Name & Middle Initial & Last Name or Official Title & Degree

Jorma Ryhänen, adj. prof.

jorma.ryhanen@hus.fi

Facility Information:

Facility Name

Töölö Hospital (Helsinki University Hospital)

City

Helsinki

Country

Finland

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Samuli Aspinen, M.D., Ph.D.

Phone

+358406360546

samuli.aspinen@hus.fi

First Name & Middle Initial & Last Name & Degree

Jorma Ryhänen, adj. prof

jorma.ryhanen@hus.fi

Facility Name

Central Hospital of Central Finland

City

Jyväskylä

Country

Finland

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Teemu Karjalainen, MD, PhD

Facility Name

Kymenlaakso Central Hospital

City

Kotka

Country

Finland

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Kaj Zilliacus, MD

Facility Name

Tampere University Hospital

City

Tampere

Country

Finland

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Veera Pikkarainen, MD

Facility Name

Turku University Hospital

City

Turku

Country

Finland

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Hanna-Stiina Taskinen, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

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

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