CapFlex PIP Implant RSA

NCT05484089 | Recruiting

• 1 other identifier: OC-2021-019
• Study Type: observational
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis Hand

Keywords

RSA; Osteoarthritis

Outcome Measures

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

  postoperative baseline, 6 weeks, 6 months, 1 year, 2 years, 5 years and 10 years.

Secondary Outcomes (7)

• Rotation in degrees

  postoperative baseline, 6 weeks, 6 months, 1 year, 2 years, 5 years and 10 years.

• Survival

  postoperative at 6 weeks, 6 months, 1 year, 2 years, 5 years and 10 years.

• Radiographic aspects

  postoperative baseline and at 6 weeks, 6 months, 1 year, 2 years, 5 years and 10 years.

• Michigan Hand Outcomes Questionnaire (MHOQ)

  postoperative baseline and at 6 weeks, 6 months, 1 year, 2 years, 5 years and 10 years.

• Patient Rated Wrist / Hand Evaluation (PRWHE)

  postoperative baseline and at 6 weeks, 6 months, 1 year, 2 years, 5 years and 10 years.

Interventions

CapFlex PIP implant DEVICE

Patients receive the CapFlex PIP implant based on regular care. During surgery tantalum markers are placed in the bone surrounding the implant.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients who will get PIP joint arthroplasty.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Reinier Haga Orthopedisch Centrum: lead

Study Sites (1)

Reinier Haga Orthopedisch Centrum

Zoetermeer, South Holland, 2725 NA, Netherlands

RECRUITING

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Central Study Contacts

N.M.C. Mathijssen

CONTACT

079 - 206 5595; Onderzoek@rhoc.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2022
• First Posted: August 2, 2022
• Study Start: October 25, 2023
• Primary Completion (Estimated): October 1, 2035
• Study Completion (Estimated): October 1, 2035
• Last Updated: October 31, 2023

Record last verified: 2023-10

Locations

NL (1)