CapFlex PIP Implant RSA
ConditionOsteoarthritis Hand
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorReinier Haga Orthopedisch Centrum
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Painful osteoarthritis
Instable communitive intra-articular PIP fractures
Age > 18 years
Patient is able to speak and write Dutch
Disqualifiers
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
Trial population
Patients who will get PIP joint arthroplasty.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
CapFlex PIP implant
DevicePatients receive the CapFlex PIP implant based on regular care. During surgery tantalum markers are placed in the bone surrounding the implant.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
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
Time frame
postoperative baseline, 6 weeks, 6 months, 1 year, 2 years, 5 years and 10 years.Secondary outcomes
1
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
Time frame
postoperative baseline, 6 weeks, 6 months, 1 year, 2 years, 5 years and 10 years.2
Survival
Survival measured by the percentage of in place implants at each timepoint
Time frame
postoperative at 6 weeks, 6 months, 1 year, 2 years, 5 years and 10 years.3
Radiographic aspects
Radiographic aspects are measured on the x-rays at each time point
Time frame
postoperative baseline and at 6 weeks, 6 months, 1 year, 2 years, 5 years and 10 years.4
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.
Time frame
postoperative baseline and at 6 weeks, 6 months, 1 year, 2 years, 5 years and 10 years.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov