Wrist OsteoarthritisNCT01906996
Proximal Row Carpectomy Versus Four Corner Fusion
An observational study of Wrist Osteoarthritis, run by Schulthess Klinik at 1 site in Switzerland.
Trial summary
There are two types of interventions to treat a post-traumatic wrist osteoarthritis: the proximal row carpectomy and the four corner fusion. They are used to reduce pain and to maintain the mobility. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Wrist Osteoarthritis
- What is being tested?
- proximal row carpectomy and four corner fusion
- Type of treatment
- Surgery or procedure
- How many people
- 114 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jul 2013to Jan 2014
- Phase
- Observational
- 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
Study population: patients with a post-traumatic wrist osteoarthritis, who are treated with a proximal row carpectomy or a four corner fusion
Who may be able to join
- post-traumatic wrist osteoarthritis
- treated with a proximal row carpectomy or four corner fusion
- signed written informed consent
Who cannot join
- no knowledge of German
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Subjective, Radiological and Functional Results After Proximal Row Carpectomy and Four Corner Fusion
There are two types of interventions to treat a post-traumatic wrist osteoarthritis: the proximal row carpectomy and the four corner fusion. They are used to reduce pain and to maintain the mobility. In previous studies are shown that the proximal row carpectomy shows a better mobility of the wrist postoperatively, whereas the four corner fusion has lower progression of radiocarpale osteoarthritis.
The purpose of this study is to compare the clinical, radiological and subjective outcomes after the treatment with a proximal row carpectomy or a four corner fusion.
Read the detailed description
Two surgical procedures are used to treat a post-traumatic wrist osteoarthritis, especially after scaphoid non-union advanced collapse (SNAC) and scapholunate advanced collapse (SLAC): the proximal row carpectomy and the four corner fusion. Both surgical procedures are rescue operations. They are used to reduce pain and to maintain the mobility, compared to a complete stiffening of the wrist.
In previous studies are shown that the proximal row carpectomy shows a better mobility of the wrist postoperatively and a lower complication rate, whereas the four corner fusion has a lower progression of radiocarpale osteoarthritis and a better grip strength.
The purpose of this study is to compare the clinical, radiological and subjective outcomes after the treatment with a proximal row carpectomy or a four corner fusion.
- Conditions
- Wrist Osteoarthritis
- Being tested
- proximal row carpectomy, four corner fusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
proximal row carpectomyProcedure or surgery
excision of the scaphoid, lunate and triquetrum
four corner fusionProcedure or surgery
excision of the scaphoid and stiffening of the lunate, capitate and triquetrum by a plate
| Study group | Role | What they receive |
|---|---|---|
| proximal row carpectomy | patients were treated with a proximal row carpectomy Receives: Procedure: proximal row carpectomy | |
| four corner fusion | patients were treated with a four corner fusion Receives: Procedure: four corner fusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Range of motion of the wrist
measurements of flexion/extension,supination/pronation and radial-/ulnarduction of the wrist
Measured: participants will be followed up by an expected average of 4.5 years
Secondary outcomes (1)
complication rate
Detection of complications of both surgical procedures
Measured: participants will be followed up by an expected average of 4.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2013 (estimated)
- Study startJul 2013
- Primary completionJan 2014
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wrist OsteoarthritisStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 114 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Schulthess Klinik
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel Herren, Schulthess Klinik
- Investigators
- Daniel B Herren, Dr. med., Principal investigator, Schulthess Klinik
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01906996
- Sponsor's protocol ID
- PRC01
- Status last verified
- Feb 2014
- First submitted
- 11 Jul 2013
- Last updated
- 27 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Subjective, Radiological and Functional Results After Proximal Row Carpectomy and Four Corner Fusion
- ClinicalTrials.gov ID
- NCT01906996
- Acronym / sponsor ID
- PRC01
- Conditions
- Wrist Osteoarthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 114 participants (estimated)
- Lead sponsor
- Schulthess KlinikUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 24 Jul 2013 (estimated)
- 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.
There are two types of interventions to treat a post-traumatic wrist osteoarthritis: the proximal row carpectomy and the four corner fusion. They are used to reduce pain and to maintain the mobility. In previous studies are shown that the proximal row carpectomy shows a better mobility of the wrist postoperatively, whereas the four corner fusion has lower progression of radiocarpale osteoarthritis.
The purpose of this study is to compare the clinical, radiological and subjective outcomes after the treatment with a proximal row carpectomy or a four corner fusion.
Detailed description
Two surgical procedures are used to treat a post-traumatic wrist osteoarthritis, especially after scaphoid non-union advanced collapse (SNAC) and scapholunate advanced collapse (SLAC): the proximal row carpectomy and the four corner fusion. Both surgical procedures are rescue operations. They are used to reduce pain and to maintain the mobility, compared to a complete stiffening of the wrist.
In previous studies are shown that the proximal row carpectomy shows a better mobility of the wrist postoperatively and a lower complication rate, whereas the four corner fusion has a lower progression of radiocarpale osteoarthritis and a better grip strength.
The purpose of this study is to compare the clinical, radiological and subjective outcomes after the treatment with a proximal row carpectomy or a four corner fusion.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| proximal row carpectomy | – | Procedure: proximal row carpectomypatients were treated with a proximal row carpectomy |
| four corner fusion | – | Procedure: four corner fusionpatients were treated with a four corner fusion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with a post-traumatic wrist osteoarthritis, who are treated with a proximal row carpectomy or a four corner fusion
Key inclusion criteria (3 listed)
- post-traumatic wrist osteoarthritis
- treated with a proximal row carpectomy or four corner fusion
- signed written informed consent
Key exclusion criteria (1 listed)
- no knowledge of German
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 |
|---|---|---|
| proximal row carpectomyexcision of the scaphoid, lunate and triquetrum | Procedure or surgery | proximal row carpectomy |
| four corner fusionexcision of the scaphoid and stiffening of the lunate, capitate and triquetrum by a plate | Procedure or surgery | four corner fusion |
Primary outcome
Range of motion of the wrist
Time frame: participants will be followed up by an expected average of 4.5 years
measurements of flexion/extension,supination/pronation and radial-/ulnarduction of the wrist
1 secondary outcome
complication rate
Time frame: participants will be followed up by an expected average of 4.5 years
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 27 Feb 2014.
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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.
Daniel B Herren, Dr. med. principal investigator
Schulthess Klinik
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Wrist Osteoarthritis, run by Schulthess Klinik at 1 site in Switzerland.
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 1 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 27 Feb 2014. 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 Switzerland. 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?
Range of motion of the wrist (time frame: participants will be followed up by an expected average of 4.5 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 27 Feb 2014.