Clinical trial NCT05484089: CapFlex PIP Implant RSA
Official title: Migration of the CapFlex-PIP Implant System for Proximal Interphalangeal Joint Arthroplasty: a 10 Year Follow up RSA Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Osteoarthritis Hand
Keywords: RSA
Osteoarthritis
Lead sponsor: Reinier Haga Orthopedisch Centrum
Sponsor class: OTHER
First posted: 2022-08-02
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who will get PIP joint arthroplasty.

Brief 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. 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: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: The change in Translation in mm
timeFrame: postoperative baseline, 6 weeks, 6 months, 1 year, 2 years, 5 years and 10 years.
Secondary outcomes:
measure: Rotation in degrees
timeFrame: postoperative baseline, 6 weeks, 6 months, 1 year, 2 years, 5 years and 10 years.
measure: Survival
timeFrame: postoperative at 6 weeks, 6 months, 1 year, 2 years, 5 years and 10 years.
measure: Radiographic aspects
timeFrame: postoperative baseline and at 6 weeks, 6 months, 1 year, 2 years, 5 years and 10 years.
measure: Michigan Hand Outcomes Questionnaire (MHOQ)
timeFrame: postoperative baseline and at 6 weeks, 6 months, 1 year, 2 years, 5 years and 10 years.
measure: Patient Rated Wrist / Hand Evaluation (PRWHE)
timeFrame: postoperative baseline and at 6 weeks, 6 months, 1 year, 2 years, 5 years and 10 years.
measure: EuroQol-5D (EQ-5D-5L)
timeFrame: postoperative baseline and at 6 weeks, 6 months, 1 year, 2 years, 5 years and 10 years.
measure: Numeric Rating Scale (NRS)
timeFrame: postoperative baseline and at 6 weeks, 6 months, 1 year, 2 years, 5 years and 10 years.
Other outcomes:
Locations:
city: Zoetermeer
country: Netherlands
facility: Reinier Haga Orthopedisch Centrum
state: Zuid-Holland
Study officials:
References: