Scapholunate Advanced Collapse (SLAC)NCT05719935
The KinematX Midcarpal Total Wrist Arthroplasty Registry
An observational study of Scapholunate Advanced Collapse (SLAC) and Scapholunate Crystalline Advanced Collapse (SCAC), run by Extremity Medical at 4 sites in United States.
Trial summary
The goal of this observational study is to learn about functional and patient reported outcomes in patient undergoing total wrist replacement with the KinematX total wrist replacement study. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Scapholunate Advanced Collapse (SLAC), Scapholunate Crystalline Advanced Collapse (SCAC), Scaphoid, Trapezium, and Trapezoid Advanced Collapse (STTAC)
- What is being tested?
- KinematX total wrist arthroplasty system
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 4 sitesUnited States
- Study dates
- 26 Apr 2021to Dec 2035
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients aged 18-85 with planned (or previously completed) total wrist arthroplasty with the KinematX total wrist are eligible for enrollment into this study
Who may be able to join
- one of the following diagnoses and planned (or previously completed) total wrist arthroplasty with the KinematX total wrist:
- osteoarthritis or post-traumatic arthritis
- scapholunate advanced collapse (SLAC/SNAC wrist),
- inflammatory arthritis (rheumatoid, psoriatic, other),
- crystalline advanced collapse (SCAC),
- STT advanced collapse (STTAC),
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- ulnar translocation,
- Kienbӧck disease,
- radial malunion
Who cannot join
- <18 years of age
- >85 years of age
- Prisoners
- Children
- Pregnant women
- Contraindications to receiving the KinematX:
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- Local, distant or systematic acute or chronic soft tissue or bony infection
- Physiologically or psychologically compromised patient
- Active wrist synovitis or severe carpal bone erosion
- Suspected or documented metal allergy or intolerance
- Insufficient extensor tendons
- Inadequate skin, bone, neural or vascular status
- Severe carpal bone malalignment, displacement, absorption, neoplastic, or carpal bone pathology
- Sepsis
- Osteomyelitis
- Uncontrolled/untreated osteoporosis or metabolic bone disease
- Metabolic or endocrinologic bone disorders
- Osteomalacia
- Distant foci of infections which may spread to the implant site
- Rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites, 4 recruiting
- Recruiting
Franciscan Health
Indianapolis, Indiana, 46237
Stephanie Alford, stephanie.alford@franciscanalliance.org
Richard Makowiec, MD
- Recruiting
Loma Linda University
Loma Linda, California, 92354
Elisabeth Clarke, EAClarke@llu.edu
Barth Riedel, MD
- Recruiting
Hospital for Special Surgery
New York, New York, 10021
Benjamin Basseri, basserib@hss.edu
Scott Wolfe, MD
- Recruiting
Florida Orthopaedic Institute
Tampa, Florida, 33637
Debbi Warren, dwarren@foreonline.org
Craig Dent, cdent@foreonline.org
About this study
Official title: The KinematX Midcarpal Total Wrist Arthroplasty: A Multicenter Prospective Registry of Clinical and Patient-Reported Outcomes
The goal of this observational study is to learn about functional and patient reported outcomes in patient undergoing total wrist replacement with the KinematX total wrist replacement study.
The main questions it aims to answer are:
Read more
- What is the range of motion (flexion, extension, radial, ulnar, grip and pinch strength) at 3-, 6-, and 12-months after surgery and yearly up to 10 years among patients having total wrist replacement with the KinematX implant.
- What are the patient reported outcomes (PROMIS, PRWE, HSS wrist expectations) at 3-, 6-, and 12-months after surgery and yearly up to 10 years among patients having total wrist replacement with the KinematX implant.
- How do range of motion and patient reported outcomes change over the 10 years after total wrist replacement surgery?
Participants will be followed according to standard of care and preoperative and post-operative information for up to 10 years after surgery will be collected and entered into an electronic data base. Patients are eligible to enroll into the registry before or after they have had their wrist replacement surgery.
- Conditions
- Scapholunate Advanced Collapse (SLAC), Scapholunate Crystalline Advanced Collapse (SCAC), Scaphoid, Trapezium, and Trapezoid Advanced Collapse (STTAC), Carpal Tunnel Syndrome (CTS), Kienbock's Disease of Adults, Radial Malunion
- Being tested
- KinematX total wrist arthroplasty system
- Keywords
- Total wrist replacement, Total wrist arthroplasty
- Medical subject headings
- Carpal Tunnel Syndrome, Arthritis, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KinematX total wrist arthroplasty systemDevice
The KinematX total wrist implant is a joint metal/polymer semi-constrained cemented prosthesis that utilizes an articulation that mimics the midcarpal joint instead of the radiocarpal joint.
| Study group | Role | What they receive |
|---|---|---|
| KinematX patients | Patients undergoing total wrist replacement with the KinematX implant. Receives: Device: KinematX total wrist arthroplasty system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Range of Motion (as assessed by physician)
Flexion, Extension, Ulnar, Radial
Measured: Up to 10 years
Secondary outcomes (8)
PROMIS Upper Extremity Physical Function 7a
7 questions designed to understand the patient's physical function in the upper extremity specifically; population average t-score is 50, with a standard deviation of 10; higher scores are better.
Measured: 3 months, 6 months, yearly up to 10 years post-surgery
PROMIS Pain Interference 8a
8 questions designed to understand how any pain experienced interferes with the patient's day to day life; population average t-score is 50, with a standard deviation of 10; lower scores are better
Measured: 3 months, 6 months, yearly up to 10 years post-surgery
PROMIS Global 10
10 questions to assess the patient's global health with subscales for physical health and mental health; Physical health t-scores range from 16.2 to 67.7; Mental health t-scores range from 21.2 to 67.6; higher scores are better
Measured: 3 months, 6 months, yearly up to 10 years post-surgery
Patient-Rated Wrist Evaluation Score (PRWE)
15 questions that assess pain and function; total scores can range from 0-100; lower scores are better
Measured: 3 months, 6 months, yearly up to 10 years post-surgery
Hospital for Special Surgery Wrist Surgery Expectations Survey
22 questions that assess how the patient expects to benefit from the surgery and a corresponding post-operative instrument that asks about actual experience; score range from 22 to 110; lower scores are better
Measured: Pre-operative and yearly up to 10 years post-surgery
Percentage of patients experiencing post-operative complications
Measured: 3 months, 6 months, yearly up to 10 years post-surgery
Percentage of patients requiring revision surgery for their implant (with or without implant replacement)
Measured: 3 months, 6 months, yearly up to 10 years post-surgery
Grip and pinch strength (as assessed by physician)
Grip and pinch strength
Measured: 3months, 6 months, yearly up to 10 years post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2023
- Study start26 Apr 2021
- Primary completionDec 2035 (estimated)
- Study completionDec 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Scapholunate Advanced Collapse (SLAC)Studies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Extremity Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Brian Smekal, Study director, Extremity Medical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05719935
- Sponsor's protocol ID
- 112020-1
- Status last verified
- Nov 2023
- First submitted
- 19 Dec 2022
- Last updated
- 15 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The KinematX Midcarpal Total Wrist Arthroplasty: A Multicenter Prospective Registry of Clinical and Patient-Reported Outcomes
- ClinicalTrials.gov ID
- NCT05719935
- Acronym / sponsor ID
- 112020-1
- Conditions
- Scapholunate Advanced Collapse (SLAC), Scapholunate Crystalline Advanced Collapse (SCAC), Scaphoid, Trapezium, and Trapezoid Advanced Collapse (STTAC), Carpal Tunnel Syndrome (CTS), Kienbock's Disease of Adults, Radial Malunion
- Keywords
- Total wrist replacement, Total wrist arthroplasty
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Extremity MedicalIndustry (pharma, biotech, devices)
- Study start
- 26 Apr 2021 (actual)
- Primary completion
- Dec 2035 (estimated)
- Study completion
- Dec 2035 (estimated)
- First posted
- 9 Feb 2023 (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.
The goal of this observational study is to learn about functional and patient reported outcomes in patient undergoing total wrist replacement with the KinematX total wrist replacement study.
The main questions it aims to answer are:
- What is the range of motion (flexion, extension, radial, ulnar, grip and pinch strength) at 3-, 6-, and 12-months after surgery and yearly up to 10 years among patients having total wrist replacement with the KinematX implant.
- What are the patient reported outcomes (PROMIS, PRWE, HSS wrist expectations) at 3-, 6-, and 12-months after surgery and yearly up to 10 years among patients having total wrist replacement with the KinematX implant.
- How do range of motion and patient reported outcomes change over the 10 years after total wrist replacement surgery?
Participants will be followed according to standard of care and preoperative and post-operative information for up to 10 years after surgery will be collected and entered into an electronic data base. Patients are eligible to enroll into the registry before or after they have had their wrist replacement surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| KinematX patients | – | Device: KinematX total wrist arthroplasty systemPatients undergoing total wrist replacement with the KinematX implant. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients aged 18-85 with planned (or previously completed) total wrist arthroplasty with the KinematX total wrist are eligible for enrollment into this study
Key inclusion criteria (9 listed)
- one of the following diagnoses and planned (or previously completed) total wrist arthroplasty with the KinematX total wrist:
Key exclusion criteria (20 listed)
- <18 years of age
- >85 years of age
- Prisoners
- Children
- Pregnant women
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 |
|---|---|---|
| KinematX total wrist arthroplasty systemThe KinematX total wrist implant is a joint metal/polymer semi-constrained cemented prosthesis that utilizes an articulation that mimics the midcarpal joint instead of the radiocarpal joint. | Device | KinematX patients |
Primary outcome
Range of Motion (as assessed by physician)
Time frame: Up to 10 years
Flexion, Extension, Ulnar, Radial
8 secondary outcomes
PROMIS Upper Extremity Physical Function 7a
Time frame: 3 months, 6 months, yearly up to 10 years post-surgery
PROMIS Pain Interference 8a
Time frame: 3 months, 6 months, yearly up to 10 years post-surgery
PROMIS Global 10
Time frame: 3 months, 6 months, yearly up to 10 years post-surgery
Patient-Rated Wrist Evaluation Score (PRWE)
Time frame: 3 months, 6 months, yearly up to 10 years post-surgery
Hospital for Special Surgery Wrist Surgery Expectations Survey
Time frame: Pre-operative and yearly up to 10 years post-surgery
Percentage of patients experiencing post-operative complications
Time frame: 3 months, 6 months, yearly up to 10 years post-surgery
Percentage of patients requiring revision surgery for their implant (with or without implant replacement)
Time frame: 3 months, 6 months, yearly up to 10 years post-surgery
Grip and pinch strength (as assessed by physician)
Time frame: 3months, 6 months, yearly up to 10 years post-surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2023.
- Individual participant dataSharing planned: No
Related trials for Scapholunate Advanced Collapse (SLAC)
Recruiting
Randomized Comparison of PARtial Wrist Fusion With or Without Triquetral Excision (PARTE)
Wrist Arthritis, Wrist Arthropathy
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.
Brian Smekal study director
Extremity Medical
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Scapholunate Advanced Collapse (SLAC) and Scapholunate Crystalline Advanced Collapse (SCAC), run by Extremity Medical at 4 sites in United States.
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 9 inclusion and 20 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: looking for participants now, as of the sponsor's last update on 15 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Brian Smekal (+1 952-836-5698, bsmekal@extremitymedical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Range of Motion (as assessed by physician) (time frame: Up to 10 years). 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 15 Nov 2023.