OsteoarthritisNCT02886078
Dorsal Versus Volar Approach for CapFlex-PIP© Implantation
A study testing Dorsal approach CapFlex arthroplasty and Volar approach CapFlex arthroplasty in people with Osteoarthritis, run by Miriam Marks at 1 site in Switzerland.
Trial summary
The primary objective is to investigate the active extension six months after implantation of the CapFlex-PIP© arthroplasty, comparing the dorsal with the volar approach. This is a randomized controlled trial including 70 patients with PIP OA indicated for CapFlex arthroplasty. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Dorsal approach CapFlex arthroplasty and Volar approach CapFlex arthroplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteSwitzerland
- Study dates
- Oct 2016to Jun 2017
- 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
- Indication for CapFlex-PIP© arthroplasty
- Patient aged 18 years and over
- Informed Consent as documented by signature
Who cannot join
- Revision surgery
- CapFlex-PIP© arthroplasty at the thumb IP joint
- Major surgery at the same finger (e.g. DIP arthrodesis)
- Ulnar/radial deviation of the PIP joint > 15°
- Patients in which a reconstruction of the collateral ligaments has to be performed
- General medical contraindication to surgery
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- German language barrier to complete the questionnaires
- Any disease process that would preclude accurate evaluation (e.g. neuromuscular, psychiatric or metabolic disorder)
- Pregnancy
- Surgery not planned by Dr. Herren, Dr. Schindele or Dr. Bodmer
- Legal incompetence
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dorsal Versus Volar Approach for CapFlex-PIP© Implantation: a Randomized Controlled Trial
The primary objective is to investigate the active extension six months after implantation of the CapFlex-PIP© arthroplasty, comparing the dorsal with the volar approach.
This is a randomized controlled trial including 70 patients with PIP OA indicated for CapFlex arthroplasty.
Read the detailed description
The CapFlex-PIP© implant is a modular gliding surface proximal interphalangeal (PIP) joint prosthesis. For implantation, there are two approaches available: The dorsal central split approach according to Swanson and the volar approach described by Simmen.
Our experiences and data from our prospective registry indicate, that the active extension of the PIP joint is better after the dorsal approach, but sometimes related with hyperextension of the PIP joint and secondary swan-neck deformity. Extension is supposed to be better after the volar approach, but associated with active and passive extension lag. Evidence of theses experiences will assist the surgeon in the preoperative planning to select the appropriate approach according to the patient's needs.
The primary objective is to investigate the active extension six months after implantation of the CapFlex-PIP© arthroplasty, comparing the dorsal with the volar approach.
This is a randomized controlled trial.
- Conditions
- Osteoarthritis
- Being tested
- Dorsal approach CapFlex arthroplasty, Volar approach CapFlex arthroplasty
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dorsal approach CapFlex arthroplastyProcedure or surgery
Arthroplasty of the PIP joint with the CapFlex implant. Surgery will be done with the dorsal approach.
Volar approach CapFlex arthroplastyProcedure or surgery
Arthroplasty of the PIP joint with the CapFlex implant. Surgery will be done with the volar approach.
| Study group | Role | What they receive |
|---|---|---|
| Dorsal approach CapFlex arthroplasty | Experimental | Arthroplasty of the PIP joint with the CapFlex implant. Surgery will be done with the dorsal approach. Receives: Procedure: Dorsal approach CapFlex arthroplasty |
| Volar approach CapFlex arthroplasty | Active comparator | Arthroplasty of the PIP joint with the CapFlex implant. Surgery will be done with the volar approach. Receives: Procedure: Volar approach CapFlex arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Active extension of the PIP joint measured with a goniometer
Measured: 6 months after surgery
Secondary outcomes (1)
Subjective function using the Brief Michigan Hand Questionnaire (briefMHQ)
Measured: 6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2016 (estimated)
- Study startOct 2016
- Primary completionJun 2017
- Study completionJun 2017
Why it stopped: Insufficient recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Miriam Marks
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Miriam Marks, Schulthess Klinik
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02886078
- Sponsor's protocol ID
- CapFlexRCT
- Status last verified
- Jun 2017
- First submitted
- 23 Aug 2016
- Last updated
- 16 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: No plan to share data
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dorsal Versus Volar Approach for CapFlex-PIP© Implantation: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02886078
- Acronym / sponsor ID
- CapFlexRCT
- Conditions
- Osteoarthritis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Insufficient recruitment
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Miriam MarksUniversity, hospital or other
- Study start
- Oct 2016 (actual)
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 1 Sep 2016 (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.
The primary objective is to investigate the active extension six months after implantation of the CapFlex-PIP© arthroplasty, comparing the dorsal with the volar approach.
This is a randomized controlled trial including 70 patients with PIP OA indicated for CapFlex arthroplasty.
Detailed description
The CapFlex-PIP© implant is a modular gliding surface proximal interphalangeal (PIP) joint prosthesis. For implantation, there are two approaches available: The dorsal central split approach according to Swanson and the volar approach described by Simmen.
Our experiences and data from our prospective registry indicate, that the active extension of the PIP joint is better after the dorsal approach, but sometimes related with hyperextension of the PIP joint and secondary swan-neck deformity. Extension is supposed to be better after the volar approach, but associated with active and passive extension lag. Evidence of theses experiences will assist the surgeon in the preoperative planning to select the appropriate approach according to the patient's needs.
The primary objective is to investigate the active extension six months after implantation of the CapFlex-PIP© arthroplasty, comparing the dorsal with the volar approach.
This is a randomized controlled trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dorsal approach CapFlex arthroplasty | Experimental | Procedure: Dorsal approach CapFlex arthroplastyArthroplasty of the PIP joint with the CapFlex implant. Surgery will be done with the dorsal approach. |
| Volar approach CapFlex arthroplasty | Active comparator | Procedure: Volar approach CapFlex arthroplastyArthroplasty of the PIP joint with the CapFlex implant. Surgery will be done with the volar approach. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Indication for CapFlex-PIP© arthroplasty
- Patient aged 18 years and over
- Informed Consent as documented by signature
Key exclusion criteria (11 listed)
- Revision surgery
- CapFlex-PIP© arthroplasty at the thumb IP joint
- Major surgery at the same finger (e.g. DIP arthrodesis)
- Ulnar/radial deviation of the PIP joint > 15°
- Patients in which a reconstruction of the collateral ligaments has to be performed
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 |
|---|---|---|
| Dorsal approach CapFlex arthroplastyArthroplasty of the PIP joint with the CapFlex implant. Surgery will be done with the dorsal approach. | Procedure or surgery | Dorsal approach CapFlex arthroplasty |
| Volar approach CapFlex arthroplastyArthroplasty of the PIP joint with the CapFlex implant. Surgery will be done with the volar approach. | Procedure or surgery | Volar approach CapFlex arthroplasty |
Primary outcome
Active extension of the PIP joint measured with a goniometer
Time frame: 6 months after surgery
1 secondary outcome
Subjective function using the Brief Michigan Hand Questionnaire (briefMHQ)
Time frame: 6 months after surgery
Results and safety
The study was stopped early (reason given: Insufficient recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2017.
- Individual participant dataSharing planned: No. No plan to share data
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dorsal approach CapFlex arthroplasty and Volar approach CapFlex arthroplasty in people with Osteoarthritis, run by Miriam Marks 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 11 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: stopped early, as of the sponsor's last update on 16 Jun 2017. 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 was stopped early (reason given: Insufficient recruitment). 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?
Active extension of the PIP joint measured with a goniometer (time frame: 6 months after surgery). 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 16 Jun 2017.