Osteoarthritis HandCapflex RSANCT05484089
CapFlex PIP Implant RSA
An observational study of Osteoarthritis Hand, run by Reinier Haga Orthopedisch Centrum at 1 site in Netherlands.
Trial summary
Rationale: Patients with osteoarthrtis (OA) of the proximal interphalangeal (PIP) joint are commonly treated with joint arthroplasty. The CapFlex PIP implant is a modular surface replacing implant, which has good short-term functional results with a relatively low complication rate. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis Hand
- What is being tested?
- CapFlex PIP implant
- Type of treatment
- Medical device
- How many people
- 36 participants
- Where
- 1 siteNetherlands
- Study dates
- 25 Oct 2023to Oct 2035
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who will get PIP joint arthroplasty.
Who may be able to join
- Indication for PIP joint arthroplasty as described in the manufacturer's guideline, namely as a result of:
- Painful osteoarthritis
- Instable communitive intra-articular PIP fractures
- Age > 18 years
- Patient is able to speak and write Dutch
- Patient is willing to participate
- Patient is able and willing to provide written informed consent
Who cannot join
- Inflammatory arthritis with significant bone loss
- Insufficient bone quality to provide adequate stability
- Known or suspected sensitivity or allergy to one or more of the implant materials
- Revision surgery
- Significant collateral instability
- Pregnancy or breastfeeding
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
Reinier Haga Orthopedisch Centrum
Zoetermeer, South Holland, 2725 NA
N.M.C. Mathijssen, 079 - 206 5595, Onderzoek@rhoc.nl
About this study
Official title: Migration of the CapFlex-PIP Implant System for Proximal Interphalangeal Joint Arthroplasty: a 10 Year Follow up RSA Study
Rationale: Patients with osteoarthrtis (OA) of the proximal interphalangeal (PIP) joint are commonly treated with joint arthroplasty. The CapFlex PIP implant is a modular surface replacing implant, which has good short-term functional results with a relatively low complication rate. To reduce implant failure and to increase long-term survival, it is important to expand knowledge about fixation and loosening patterns. By using model-based roentgen stereogrammaetric analysis (mRSA), the migration pattern of the implant over time can be calculated.
Objective: The primary objective is to assess the fixation and migration patterns of the CapFlex PIP implant system (produced and developed by several companies of KLS Martin Group) in vivo, using mRSA, over 10 years. Secondary objectives are to analyse survival, clinical scores and radiographic aspects of the CapFlex PIP implant system.
Read more
Study design: A prospective cohort study with 10 years follow-up, in which 36 patients will be enrolled. Patients will be evaluated preoperatively, at 6 weeks, 6 months, 1 year, 2 years 5 years and 10 years.
Study population: Patients 18 years or older who require a proximal interphalangeal joint arthroplasty as a result of osteoarthritis of a proximal interphalangeal joint.
Main study parameters/endpoints: The main study parameters are the migration of the CapFlex PIP implant system of the distal as well as the proximal component (presented in x-, y- and z-direction). Secondary study parameters are the survival of the CapFlex PIP implant system, clinical scores and radiographic aspects.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Patients participating in the study will have the same risks when not participating in the study. Patients are asked to spend time to fill in the questionnaires and to have 3 extra visits to the hospital, next to the standard visits. Patients will have more follow up visits and will be followed using RSA analysis, which has as advantage that possible complications might be noticed earlier compared to normal follow up.
- Conditions
- Osteoarthritis Hand
- Being tested
- CapFlex PIP implant
- Keywords
- RSA, Osteoarthritis
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CapFlex PIP implantDevice
Patients receive the CapFlex PIP implant based on regular care. During surgery tantalum markers are placed in the bone surrounding the implant.
What is being measured
The primary outcome is the main question the study is designed to answer.
The change in Translation in mm
Migration will be expressed in the change in translation measured over time compared to the postoperative baseline. Translation is expressed in mm and is given in 3 directions, namely along the x-, y- and z-axes
Measured: postoperative baseline, 6 weeks, 6 months, 1 year, 2 years, 5 years and 10 years.
Secondary outcomes (7)
Rotation in degrees
Migration will be expressed in the change in rotation measured over time compared to the postoperative baselin. Rotation is expressed in degrees and is given in 3 directions, namely along the x-, y- and z-axes
Measured: postoperative baseline, 6 weeks, 6 months, 1 year, 2 years, 5 years and 10 years.
Survival
Survival measured by the percentage of in place implants at each timepoint
Measured: postoperative at 6 weeks, 6 months, 1 year, 2 years, 5 years and 10 years.
Radiographic aspects
Radiographic aspects are measured on the x-rays at each time point
Measured: postoperative baseline and at 6 weeks, 6 months, 1 year, 2 years, 5 years and 10 years.
Michigan Hand Outcomes Questionnaire (MHOQ)
The MHOQ is a validated tool for assessing functional outcome and is divided in six subscales. Each subscale has a formula to calculate a score from 0 (severe disability) to 100 (no disability). The final score is the summation divided by six and goes from 0 (severe disability) to 100 (no disability).
The MHOQ will be assessed at each time point.
Measured: postoperative baseline and at 6 weeks, 6 months, 1 year, 2 years, 5 years and 10 years.
Patient Rated Wrist / Hand Evaluation (PRWHE)
The PRWHE measures the patients view on pain, function and cosmetics of the hand/wrist. The maximum score is 150. A high score indicates presence of pain and disability, a low score indicates the absence of pain and disability.
The PRWHE will be assessed at each time point.
Measured: postoperative baseline and at 6 weeks, 6 months, 1 year, 2 years, 5 years and 10 years.
EuroQol-5D (EQ-5D-5L)
The EQ-5D-5L is a general health-related quality of life questionnaire. The EQ-5D-5L will be assessed at each time point.
Measured: postoperative baseline and at 6 weeks, 6 months, 1 year, 2 years, 5 years and 10 years.
Numeric Rating Scale (NRS)
The NRS measures the amount of pain experienced by the patient form 0 (no pain) to 10 (worst pain imaginable).
The NRS will be assessed at each time point.
Measured: postoperative baseline and at 6 weeks, 6 months, 1 year, 2 years, 5 years and 10 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2022
- Study start25 Oct 2023
- Primary completionOct 2035 (estimated)
- Study completionOct 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis HandStudies 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
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Reinier Haga Orthopedisch Centrum
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05484089
- Sponsor's protocol ID
- OC-2021-019
- Acronym
- Capflex RSA
- Status last verified
- Oct 2023
- First submitted
- 25 Jul 2022
- Last updated
- 31 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Migration of the CapFlex-PIP Implant System for Proximal Interphalangeal Joint Arthroplasty: a 10 Year Follow up RSA Study
- ClinicalTrials.gov ID
- NCT05484089
- Acronym / sponsor ID
- Capflex RSA / OC-2021-019
- Conditions
- Osteoarthritis Hand
- Keywords
- RSA, Osteoarthritis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Reinier Haga Orthopedisch CentrumUniversity, hospital or other
- Study start
- 25 Oct 2023 (actual)
- Primary completion
- Oct 2035 (estimated)
- Study completion
- Oct 2035 (estimated)
- First posted
- 2 Aug 2022 (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.
Rationale: Patients with osteoarthrtis (OA) of the proximal interphalangeal (PIP) joint are commonly treated with joint arthroplasty. The CapFlex PIP implant is a modular surface replacing implant, which has good short-term functional results with a relatively low complication rate. To reduce implant failure and to increase long-term survival, it is important to expand knowledge about fixation and loosening patterns. By using model-based roentgen stereogrammaetric analysis (mRSA), the migration pattern of the implant over time can be calculated.
Objective: The primary objective is to assess the fixation and migration patterns of the CapFlex PIP implant system (produced and developed by several companies of KLS Martin Group) in vivo, using mRSA, over 10 years. Secondary objectives are to analyse survival, clinical scores and radiographic aspects of the CapFlex PIP implant system.
Study design: A prospective cohort study with 10 years follow-up, in which 36 patients will be enrolled. Patients will be evaluated preoperatively, at 6 weeks, 6 months, 1 year, 2 years 5 years and 10 years.
Study population: Patients 18 years or older who require a proximal interphalangeal joint arthroplasty as a result of osteoarthritis of a proximal interphalangeal joint.
Main study parameters/endpoints: The main study parameters are the migration of the CapFlex PIP implant system of the distal as well as the proximal component (presented in x-, y- and z-direction). Secondary study parameters are the survival of the CapFlex PIP implant system, clinical scores and radiographic aspects.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Patients participating in the study will have the same risks when not participating in the study. Patients are asked to spend time to fill in the questionnaires and to have 3 extra visits to the hospital, next to the standard visits. Patients will have more follow up visits and will be followed using RSA analysis, which has as advantage that possible complications might be noticed earlier compared to normal follow up.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who will get PIP joint arthroplasty.
Key inclusion criteria (7 listed)
- Indication for PIP joint arthroplasty as described in the manufacturer's guideline, namely as a result of:
- Age > 18 years
- Patient is able to speak and write Dutch
- Patient is willing to participate
- Patient is able and willing to provide written informed consent
Key exclusion criteria (6 listed)
- Inflammatory arthritis with significant bone loss
- Insufficient bone quality to provide adequate stability
- Known or suspected sensitivity or allergy to one or more of the implant materials
- Revision surgery
- Significant collateral instability
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 |
|---|---|---|
| CapFlex PIP implantPatients receive the CapFlex PIP implant based on regular care. During surgery tantalum markers are placed in the bone surrounding the implant. | Device | – |
Primary outcome
The change in Translation in mm
Time frame: postoperative baseline, 6 weeks, 6 months, 1 year, 2 years, 5 years and 10 years.
Migration will be expressed in the change in translation measured over time compared to the postoperative baseline. Translation is expressed in mm and is given in 3 directions, namely along the x-, y- and z-axes
7 secondary outcomes
Rotation in degrees
Time frame: postoperative baseline, 6 weeks, 6 months, 1 year, 2 years, 5 years and 10 years.
Survival
Time frame: postoperative at 6 weeks, 6 months, 1 year, 2 years, 5 years and 10 years.
Radiographic aspects
Time frame: postoperative baseline and at 6 weeks, 6 months, 1 year, 2 years, 5 years and 10 years.
Michigan Hand Outcomes Questionnaire (MHOQ)
Time frame: postoperative baseline and at 6 weeks, 6 months, 1 year, 2 years, 5 years and 10 years.
Patient Rated Wrist / Hand Evaluation (PRWHE)
Time frame: postoperative baseline and at 6 weeks, 6 months, 1 year, 2 years, 5 years and 10 years.
EuroQol-5D (EQ-5D-5L)
Time frame: postoperative baseline and at 6 weeks, 6 months, 1 year, 2 years, 5 years and 10 years.
Numeric Rating Scale (NRS)
Time frame: postoperative baseline and at 6 weeks, 6 months, 1 year, 2 years, 5 years and 10 years.
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 31 Oct 2023.
- Individual participant dataSharing planned: Undecided
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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.
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 Osteoarthritis Hand, run by Reinier Haga Orthopedisch Centrum at 1 site in Netherlands.
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 7 inclusion and 6 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 31 Oct 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 Netherlands. 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 N.M.C. Mathijssen (079 - 206 5595, Onderzoek@rhoc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change in Translation in mm (time frame: postoperative baseline, 6 weeks, 6 months, 1 year, 2 years, 5 years and 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 31 Oct 2023.