Wrist ArthritisPROOF IINCT04403958
The Use of Proximal Carpal Row Versus Iliac Crest as Bone Graft in Total Wrist Fusion
A study testing PRC and TWA in people with Wrist Arthritis and Fusion; Joint, run by Töölö Hospital.
Trial summary
Study purpose is to compare the outcome after total wrist arthrodesis (TWA) with proximal carpal row (Proximal Row Carpectomy = PRC) as bone graft versus iliac crest cancellous bone graft. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Wrist Arthritis, Fusion; Joint
- What is being tested?
- PRC and TWA
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2021to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 - 75
- Symptom duration > 3 months
- American Society of Anaesthesiologists physical status (ASA) I-III
- Fluent in written and spoken Finnish
Who cannot join
- 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)
- Ulnar variance > 1 mm
- Wrist pain treatable with partial wrist fusion
Show all 10Show fewer
- Previous partial wrist fusion
- Alcohol or drug abuse
- Neurological condition affecting upper limb function
- Less than 6 months after another operation of the same upper limb
Trial locations and contacts
No sites are listed yet.
Jorma Ryhänen, adj. prof. contact
About this study
Official title: The Use of Proximal Carpal Row Versus Iliac Crest Bone Graft in Total Wrist Fusion - a Randomized Controlled Multicenter Trial Comparing Two Operative Techniques (PROOF II - Trial)
Study purpose is to compare the outcome after total wrist arthrodesis (TWA) with proximal carpal row (Proximal Row Carpectomy = PRC) as bone graft versus iliac crest cancellous bone graft.
Patients with radiologically and clinically confirmed advanced osteoarthritis are randomized (1:1 computer generated sequence with random block size) to two parallel groups and will undergo either total wrist arthrodesis with PRC or TWA with iliac crest bone grafting.
Baseline data is collected preoperatively and is a follow-up visits at every 6 weeks after the surgery is arranged until the wrist is fused. The primary end-point is 6 months and the primary outcome is fusion rate.
- Conditions
- Wrist Arthritis, Fusion; Joint
- Being tested
- PRC, TWA
- Medical subject headings
- Ankylosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRCProcedure or surgery
Total wrist arthrodesis with dorsal plate using proximal row of the wrist as bone graft
TWAProcedure or surgery
Total wrist arthrodesis with dorsal plate using iliac crest as bone graft
| Study group | Role | What they receive |
|---|---|---|
| PRC | Experimental | Total wrist arthrodesis with PRC and dorsal plate Receives: Procedure: PRC |
| TWA | Active comparator | Total wrist arthrodesis with dorsal plate Receives: Procedure: TWA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fusion rate (percent)
Measured: 6 months
Secondary outcomes (7)
Pain (Visual Analogue Scale)
The VAS is derived by health care professional question of pain in scale 0 to 100 mm (0 mm =no pain, 100 mm =worst possible pain)
Measured: 6 months
Patient-Rated Wrist Evaluation (PRWE)
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)
Measured: 6 months
Quick-Disabilities of the Arm, Shoulder and Hand (QuickDASH)
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)
Measured: 6 months
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
Measured: 6 months
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
Measured: 6 months
Operative time
Operative time is measured in minutes for time in the operation theatre and time used for surgery
Measured: Perioperative
Complications
Incidence of complications (i.e. non-union, fracture, re-operation, infection, hematoma, iatrogenic tendon/nerve/arterial injury, complex regional pain syndrome) is recorded and compared between study groups.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2020
- Study start1 Sep 2021 (estimated)
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wrist ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Töölö Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Turku University Hospital, Kymenlaakso Central Hospital Kotka Finland
- Responsible party
- Principal investigator, Samuli Aspinen, Töölö Hospital
- Investigators
- Samuli Aspinen, M.D., Ph.D., Principal investigator, HUS Töölö Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04403958
- Sponsor's protocol ID
- 1467/2020
- Acronym
- PROOF II
- Status last verified
- Mar 2021
- First submitted
- 21 May 2020
- Last updated
- 30 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Proximal Carpal Row Versus Iliac Crest Bone Graft in Total Wrist Fusion - a Randomized Controlled Multicenter Trial Comparing Two Operative Techniques (PROOF II - Trial)
- ClinicalTrials.gov ID
- NCT04403958
- Acronym / sponsor ID
- PROOF II / 1467/2020
- Conditions
- Wrist Arthritis, Fusion; Joint
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Töölö HospitalUniversity, hospital or other
- Collaborators
- Turku University Hospital, Kymenlaakso Central Hospital Kotka Finland
- Study start
- 1 Sep 2021 (estimated)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 27 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study purpose is to compare the outcome after total wrist arthrodesis (TWA) with proximal carpal row (Proximal Row Carpectomy = PRC) as bone graft versus iliac crest cancellous bone graft.
Patients with radiologically and clinically confirmed advanced osteoarthritis are randomized (1:1 computer generated sequence with random block size) to two parallel groups and will undergo either total wrist arthrodesis with PRC or TWA with iliac crest bone grafting.
Baseline data is collected preoperatively and is a follow-up visits at every 6 weeks after the surgery is arranged until the wrist is fused. The primary end-point is 6 months and the primary outcome is fusion rate.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PRC | Experimental | Procedure: PRCTotal wrist arthrodesis with PRC and dorsal plate |
| TWA | Active comparator | Procedure: TWATotal wrist arthrodesis with dorsal plate |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18 - 75
- Symptom duration > 3 months
- American Society of Anaesthesiologists physical status (ASA) I-III
- Fluent in written and spoken Finnish
Key exclusion criteria (10 listed)
- 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)
- Ulnar variance > 1 mm
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PRCTotal wrist arthrodesis with dorsal plate using proximal row of the wrist as bone graft | Procedure or surgery | PRC |
| TWATotal wrist arthrodesis with dorsal plate using iliac crest as bone graft | Procedure or surgery | TWA |
Primary outcome
Fusion rate (percent)
Time frame: 6 months
7 secondary outcomes
Pain (Visual Analogue Scale)
Time frame: 6 months
Patient-Rated Wrist Evaluation (PRWE)
Time frame: 6 months
Quick-Disabilities of the Arm, Shoulder and Hand (QuickDASH)
Time frame: 6 months
Global improvement
Time frame: 6 months
Grip strength
Time frame: 6 months
Operative time
Time frame: Perioperative
Complications
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jorma Ryhänen, adj. prof. contact
Samuli Aspinen, M.D., Ph.D. principal investigator
HUS Töölö Hospital
Questions about this trial
What is this clinical trial studying?
A study testing PRC and TWA in people with Wrist Arthritis and Fusion; Joint, run by Töölö Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Samuli Aspinen, M.D., Ph.D. (+358406360546, samuli.aspinen@hus.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fusion rate (percent) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2021.