Wrist ArthritisNCT02080663
Long-term Outcome of Proximal Row Carpectomy. Influence of the Shape of the Capitate
An observational study of Wrist Arthritis, run by University Hospital Pellenberg at 1 site in Belgium.
Trial summary
In cases of severe arthritis of the wrist, surgical removal of the scaphoid, lunate and triquetrum bones or proximal row carpectomy (PRC) is a well-known procedure. This procedure converts the wrist in a simple hinged joint but allows us to preserve a certain range of motion in the wrist. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Wrist Arthritis
- What is being tested?
- Proximal row carpectomy
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteBelgium
- Study dates
- Mar 2014to Jul 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients who underwent a Proximal row carpectomy in our institution more than 10 year ago will be contacted for review
Who may be able to join
- All patients who underwent a Proximal row carpectomy
Who cannot join
- Bilateral procedure
Trial locations and contacts
1 site in 1 country.
About this study
In cases of severe arthritis of the wrist, surgical removal of the scaphoid, lunate and triquetrum bones or proximal row carpectomy (PRC) is a well-known procedure. This procedure converts the wrist in a simple hinged joint but allows us to preserve a certain range of motion in the wrist. One of the main disadvantages of PRC is the risk of developing arthritis between the head of the capitate and the lunate fossa. The long-term follow-up of this procedure has always been a reason for concern. The investigators set up this retrospective study to evaluate the long-term results of the procedure in the investigators institution.
Also, the shape of the head of the capitate may play a role in the development of arthritis. A more round shape could distribute the forces more equally and thus prevent the progression of cartilage damage
Read more
The study hypothesis is:
- PRC preserves range of motion and force in the long term (more than 10 years postoperatively).
- A more round head of the capitate is associated with an increased risk of developing arthritis in the new joint.
Read the detailed description
We invite all patients who underwent a PRC at our institution with a follow-up of more than 10 years for review.
Questions
- VAS pain in rest and during activity
- Pain is quantified as none, minimal (pain with strenuous activity), moderate (pain with daily activity), or severe (pain at rest).
- If pain, use of analgetics, splint, …
- quick DASH
- patient related wrist evaluation (PRWE) score. form-36 (SF-36) general health status outcome ?
- Satisfaction, do it again?
- Complications? Re-operations?
- Return to work after operation, which job (manual labor?) changed job due to wrist problems? Worker's compensation claims?
Clinical review
- grip force + other side to compare (Jamar Dynamometer)
- pinch grip + other side to compare
- range of motion measurement:
- absolute and compared to other side
- flexion-extension, ulnar-radial deviation and prosupination
Radiography:
- Standard anterioposterior and lateral wrist radiography performed to evaluate the onset or degree of arthritis.
- Radiocapitate arthrosis grading:
- None
- Minimal (joint space narrowing alone),
- Moderate (joint space narrowing with adjacent subchondral sclerosis)
- severe (bone collapse, erosion, or subchondral cyst formation)
- Oldest radiography of each patient was retrieved and the shape of the capitate evaluated.
- If available, a pre-operative MRI scan could also be interpreted. (Probably no MRI's available, but MRI gives a better indication of the shape of the capitate than plain X-ray).
- Review: documentation of intra-operative findings concerning capitate and lunate fossa.
Statistical analysis
- Student's t-test on the numerical data
- Wilcoxon signed- rank test on the visual analog scales
- Differences significant at p < .05. Two-tailed tests in all cases.
- Subgroups according to initial diagnosis
- Compare results with the initial follow-up to evaluate the prospective value of this follow-up moment.
- Conditions
- Wrist Arthritis
- Being tested
- Proximal row carpectomy
- Keywords
- carpectomy, proximal row, long-term, wrist, arthritis
- Medical subject headings
- Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proximal row carpectomyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Proximal row carpectomy | Proximal row carpectomy Receives: Procedure: Proximal row carpectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
quick DASH score
The Disability of Arm, Shoulder and Hand score is a standardised outcome measure for upper limb evaluation.
Measured: more than 10 year after operation
Secondary outcomes (1)
Arthritis between capitate and lunate fossa
radiographic evaluation of arthritis in the wrist:
- None
- Minimal (joint space narrowing alone),
- Moderate (joint space narrowing with adjacent subchondral sclerosis)
- Severe (bone collapse, erosion, or subchondral cyst formation)
Measured: 10 years after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2014 (estimated)
- Study startMar 2014
- Primary completionJun 2014 (estimated)
- Study completionJul 2014 (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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Pellenberg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maarten Van Nuffel, University Hospital Pellenberg
- Investigators
- Maarten Van Nuffel, M.D., Principal investigator, Universitaire Ziekenhuizen KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02080663
- Sponsor's protocol ID
- PRC Van Nuffel De Smet
- Status last verified
- Mar 2014
- First submitted
- 4 Mar 2014
- Last updated
- 7 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Outcome of Proximal Row Carpectomy. Influence of the Shape of the Capitate
- ClinicalTrials.gov ID
- NCT02080663
- Acronym / sponsor ID
- PRC Van Nuffel De Smet
- Conditions
- Wrist Arthritis
- Keywords
- carpectomy, proximal row, long-term, wrist, arthritis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University Hospital PellenbergUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Jun 2014 (estimated)
- Study completion
- Jul 2014 (estimated)
- First posted
- 6 Mar 2014 (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.
In cases of severe arthritis of the wrist, surgical removal of the scaphoid, lunate and triquetrum bones or proximal row carpectomy (PRC) is a well-known procedure. This procedure converts the wrist in a simple hinged joint but allows us to preserve a certain range of motion in the wrist. One of the main disadvantages of PRC is the risk of developing arthritis between the head of the capitate and the lunate fossa. The long-term follow-up of this procedure has always been a reason for concern. The investigators set up this retrospective study to evaluate the long-term results of the procedure in the investigators institution.
Also, the shape of the head of the capitate may play a role in the development of arthritis. A more round shape could distribute the forces more equally and thus prevent the progression of cartilage damage
The study hypothesis is:
- PRC preserves range of motion and force in the long term (more than 10 years postoperatively).
- A more round head of the capitate is associated with an increased risk of developing arthritis in the new joint.
Detailed description
We invite all patients who underwent a PRC at our institution with a follow-up of more than 10 years for review.
Questions
- VAS pain in rest and during activity
- Pain is quantified as none, minimal (pain with strenuous activity), moderate (pain with daily activity), or severe (pain at rest).
- If pain, use of analgetics, splint, …
- quick DASH
- patient related wrist evaluation (PRWE) score. form-36 (SF-36) general health status outcome ?
- Satisfaction, do it again?
- Complications? Re-operations?
- Return to work after operation, which job (manual labor?) changed job due to wrist problems? Worker's compensation claims?
Clinical review
- grip force + other side to compare (Jamar Dynamometer)
- pinch grip + other side to compare
- range of motion measurement:
- absolute and compared to other side
- flexion-extension, ulnar-radial deviation and prosupination
Radiography:
- Standard anterioposterior and lateral wrist radiography performed to evaluate the onset or degree of arthritis.
- Radiocapitate arthrosis grading:
- None
- Minimal (joint space narrowing alone),
- Moderate (joint space narrowing with adjacent subchondral sclerosis)
- severe (bone collapse, erosion, or subchondral cyst formation)
- Oldest radiography of each patient was retrieved and the shape of the capitate evaluated.
- If available, a pre-operative MRI scan could also be interpreted. (Probably no MRI's available, but MRI gives a better indication of the shape of the capitate than plain X-ray).
- Review: documentation of intra-operative findings concerning capitate and lunate fossa.
Statistical analysis
- Student's t-test on the numerical data
- Wilcoxon signed- rank test on the visual analog scales
- Differences significant at p < .05. Two-tailed tests in all cases.
- Subgroups according to initial diagnosis
- Compare results with the initial follow-up to evaluate the prospective value of this follow-up moment.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Proximal row carpectomy | – | Procedure: Proximal row carpectomyProximal row carpectomy |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients who underwent a Proximal row carpectomy in our institution more than 10 year ago will be contacted for review
Key inclusion criteria (1 listed)
- All patients who underwent a Proximal row carpectomy
Key exclusion criteria (1 listed)
- Bilateral procedure
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 carpectomy | Procedure or surgery | Proximal row carpectomy |
Primary outcome
quick DASH score
Time frame: more than 10 year after operation
The Disability of Arm, Shoulder and Hand score is a standardised outcome measure for upper limb evaluation.
1 secondary outcome
Arthritis between capitate and lunate fossa
Time frame: 10 years after operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 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.
Maarten Van Nuffel, M.D. principal investigator
Universitaire Ziekenhuizen KU Leuven
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 Arthritis, run by University Hospital Pellenberg at 1 site in Belgium.
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 1 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: status not confirmed, as of the sponsor's last update on 7 Mar 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 Belgium. 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?
Results are not available in the source record.
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?
quick DASH score (time frame: more than 10 year after operation). 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 7 Mar 2014.