Short Term Follow-up of Patient Implanted With the Proximal Interphalangeal Implant

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

156 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-04-30

Study Completion Date

2012-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Hammertoe and ClawToe are ones of the most common foot deformities. The second toe is the most frequently affected, but the other small toes may also be involved. When nonoperative treatment fails, surgery often is recommended. One surgical option is the arthrodesis of the Proximal Interphalangeal (PIP) joint. This arthrodesis is technically demanding, its needs:

* Internal fixation;
* Interphalangeal Compression;
* Anatomic PIP joint plantar flexion angle. The implant Ipp-On has been developed for this specific arthrodesis. The objective of this study is to evaluate the efficacy and safety of the Proximal Interphalangeal Implant: Ipp-On at short term follow up.

The safety of the Ipp-On will be described in terms of rate of device related complications.

The efficacy of the Ipp-On will be described in terms of fusion rate at 6 months.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Function Following Thumb MP Fusion and IP Fusion

NCT03661281

Osteoarthritis

COMPLETED NA

Short Versus Standard Intramedullary Nail for Trochanteric Hip Fractures

NCT02680028

Hip Fracture

COMPLETED NA

CapFlex-PIP© Motion

NCT02425319

Finger Joint Arthroplasty Replacement +1 more

COMPLETED

Ankle Arthrodesis Nail for 2-level Pathologic Tibial Fracture

NCT04940754

Bone Metastases Fracture Nonunion Bone Lesion

UNKNOWN NA

Proximal Interphalangeal Joint Arthroplasty Using a Graft From the Capitate

NCT01479738

Recurrent Dislocation of Hand

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hammer Toe Claw Toe Shortening 2nd Toe Revision of Arthrodesis or Arthroplasty Failure

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Ipp-On

Patient implanted with the Ipp-On

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Any patient who needs a proximal interphalangeal joint arthrodesis for whose surgeon has recommended that a proximal Interphalangeal Implant Ipp-On be implanted
* Age \>= 18 years
* Have willingness to give his/her Data Transfer Authorization

Exclusion Criteria

* Contraindication of the implantation of the Ipp-On The implant should not be used in a patient who has currently, or who has a history of: • Active local or systemic infection

* Severe peripheral vascular disease
* Severe longitudinal deformity
* Insufficient quantity or quality of bone to permit stabilization of the arthrodesis
* Conditions that restrict the patient's ability or willingness to follow postoperative instructions during the healing process
* Suspected or documented metal allergy or intolerance.
* History of prior mental illness or patient demonstrates that their mental capacity may interfere with their ability to follow the study protocol

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No