Osteoarthritis WristESWWANCT04235972
Evaluation of Staple Watson Wrist Arthrodesis
A study testing Follow-up consultation in people with Osteoarthritis Wrist, run by Rennes University Hospital at 1 site in France.
Trial summary
When the wrist is damaged, for traumatic or degenerative reasons, the cartilage is worn out and the bones rub together: this is osteoarthritis. In order to stop this pain, it may be necessary to block these bones from each other, sacrificing mobility to achieve indolence. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis Wrist
- What is being tested?
- Follow-up consultation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteFrance
- Study dates
- 3 Aug 2020to 7 Jan 2021
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult Patients
- All patients operated on for a 4-bones arthrodesis performed by stapling at the CHU RENNES between 1 January 2008 and 31 December 2017 with 4fusion stapling
- Patients who gave consent after full information
Who cannot join
- Refusal to participate after information
- Protected adults
- Person deprived of liberty
Trial locations and contacts
1 site in 1 country.
About this study
When the wrist is damaged, for traumatic or degenerative reasons, the cartilage is worn out and the bones rub together: this is osteoarthritis. In order to stop this pain, it may be necessary to block these bones from each other, sacrificing mobility to achieve indolence.
Multiple techniques are described according to the type of osteoarthritis and for each type of osteoarthritis itself, but the principle remains the same. The methods currently commonly proposed are the staple and the screwed plate.
The aim of the study is to evaluate the surgical practice of the Orthopaedics and Traumatology department of the University Hospital of Rennes, and its long-term results, as this type of surgery is intended to be definitive.
Read the detailed description
The surgery performed in the Orthopaedics and Traumatology department of the University Hospital of Rennes, has 2 notable points: its technique and its equipment.
- The procedure is based on the staples 4Fusion1 (Stryker/Memometal), which is still poorly assessed in the literature.
- The surgical procedure has several technical specificities: intra osseous cartilage freshening and preservation of the lunotriquetral ligament if intact.
- Conditions
- Osteoarthritis Wrist
- Being tested
- Follow-up consultation
- Keywords
- orthopaedic surgery, Staples
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Follow-up consultationOther
A follow-up consultation is organized which includes: A clinical examination with standard data collection as well as a face and profile radiograph of the operated wrist.
| Study group | Role | What they receive |
|---|---|---|
| Arthrodesis surgery patients | Other | A follow-up consultation is organized which includes: A clinical examination with standard data collection as well as a face and profile radiograph of the operated wrist. Receives: Other: Follow-up consultation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of the surgical procedure
Assessement of the bones consolidation at at least 6 weeks post-surgery, using a radiological criterion : 3 out of 4 line spacing merged
Measured: Day 1
Secondary outcomes (8)
Pain assessment
Evolution in pain reported by the patient by a pain assessment scale, with reference to preoperative assessment.
Evaluation is based on the visual analog scale (VAS) in which the patients select a whole number (0-10 integers) that best reflects the intensity of their pain
Measured: Day 1
Grip force
Change of the grip force measured by Jamar's hydraulic dynamometer, compared to pre-operative assessment
Measured: Day 1
Functional assessment of the wrist with Mayo Wrist Score
International validated functional score. This evaluation yields a total score out of 100 points qualified as poor if <65 up to Excellent if >90.
Measured: Day 1
Functional assessment of the wrist with Quick Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire
International validated functional score. The Quick DASH tool uses a 5-point Likert scale from which the patient can select an appropriate number corresponding to his/her severity level/ function level
Measured: Day 1
Functional assessment of the wrist with Patient-Rated Wrist Evaluation
International validated functional score. The Patient-Rated Wrist Evaluation (PRWE) allows patients to rate their levels of wrist pain and disability from 0 to 10
Measured: Day 1
Patient's overall satisfaction about surgery
Patient's overall satisfaction assessed by the question: "Would you do the surgery again? (balance between 0 and 10)"
Measured: Day 1
Material hindrance
Specific items assessed during clinical evaluations. Quoted as 1 if at least one of the following events is evoked : Material-related pain, skin irritation, re-intervention for remote ablation
Measured: Day 1
Mean mobility arc
Measurement of the arc of mobility in flexion - extension by goniometer
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2020
- Study start3 Aug 2020
- Primary completion7 Jan 2021
- Study completion7 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis WristStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Warren KIM, MD, Study director, Rennes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04235972
- Sponsor's protocol ID
- 35RC19_8861
- Other IDs
- 2019-A01553-54
- Acronym
- ESWWA
- Status last verified
- May 2023
- First submitted
- 26 Dec 2019
- Last updated
- 23 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mevel G, De Geyer A, Kim W, Ebalard M, Ropars M, Dreano T. Four-corner arthrodesis using the 4Fusion(R) quadripodal shape memory staple: a long-term review. J Hand Surg Eur Vol. 2022 Apr;47(4):387-392. doi: 10.1177/17531934211063614. Epub 2021 Dec 1.
PubMed 34851782
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Staple Watson Wrist Arthrodesis
- ClinicalTrials.gov ID
- NCT04235972
- Acronym / sponsor ID
- ESWWA / 35RC19_8861
- Conditions
- Osteoarthritis Wrist
- Keywords
- orthopaedic surgery, Staples
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- 3 Aug 2020 (actual)
- Primary completion
- 7 Jan 2021 (actual)
- Study completion
- 7 Jan 2021 (actual)
- First posted
- 22 Jan 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.
When the wrist is damaged, for traumatic or degenerative reasons, the cartilage is worn out and the bones rub together: this is osteoarthritis. In order to stop this pain, it may be necessary to block these bones from each other, sacrificing mobility to achieve indolence.
Multiple techniques are described according to the type of osteoarthritis and for each type of osteoarthritis itself, but the principle remains the same. The methods currently commonly proposed are the staple and the screwed plate.
The aim of the study is to evaluate the surgical practice of the Orthopaedics and Traumatology department of the University Hospital of Rennes, and its long-term results, as this type of surgery is intended to be definitive.
Detailed description
The surgery performed in the Orthopaedics and Traumatology department of the University Hospital of Rennes, has 2 notable points: its technique and its equipment.
- The procedure is based on the staples 4Fusion1 (Stryker/Memometal), which is still poorly assessed in the literature.
- The surgical procedure has several technical specificities: intra osseous cartilage freshening and preservation of the lunotriquetral ligament if intact.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arthrodesis surgery patients | Other | Other: Follow-up consultationA follow-up consultation is organized which includes: A clinical examination with standard data collection as well as a face and profile radiograph of the operated wrist. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult Patients
- All patients operated on for a 4-bones arthrodesis performed by stapling at the CHU RENNES between 1 January 2008 and 31 December 2017 with 4fusion stapling
- Patients who gave consent after full information
Key exclusion criteria (3 listed)
- Refusal to participate after information
- Protected adults
- Person deprived of liberty
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 |
|---|---|---|
| Follow-up consultationA follow-up consultation is organized which includes: A clinical examination with standard data collection as well as a face and profile radiograph of the operated wrist. | Other | Arthrodesis surgery patients |
Primary outcome
Assessment of the surgical procedure
Time frame: Day 1
Assessement of the bones consolidation at at least 6 weeks post-surgery, using a radiological criterion : 3 out of 4 line spacing merged
8 secondary outcomes
Pain assessment
Time frame: Day 1
Grip force
Time frame: Day 1
Functional assessment of the wrist with Mayo Wrist Score
Time frame: Day 1
Functional assessment of the wrist with Quick Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire
Time frame: Day 1
Functional assessment of the wrist with Patient-Rated Wrist Evaluation
Time frame: Day 1
Patient's overall satisfaction about surgery
Time frame: Day 1
Material hindrance
Time frame: Day 1
Mean mobility arc
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2023.
- Results publication: PubMed 34851782Mevel G, De Geyer A, Kim W, Ebalard M, Ropars M, Dreano T. Four-corner arthrodesis using the 4Fusion(R) quadripodal shape memory staple: a long-term review. J Hand Surg Eur Vol. 2022 Apr;47(4):387-392. doi: 10.1177/17531934211063614. Epub 2021 Dec 1.
- 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.
Warren KIM, MD study director
Rennes University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Follow-up consultation in people with Osteoarthritis Wrist, run by Rennes University Hospital at 1 site in France.
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 3 inclusion and 3 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: finished, as of the sponsor's last update on 23 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of the surgical procedure (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04235972, which also lists 1 linked publication.
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 23 May 2023.