Performance and Safety Evaluation of Inion CompressOn Screw in Foot and Ankle Surgeries. PMCF Investigation

The Performance and Safety Evaluation of Bioabsorbable Headless Inion CompressOn Screws in Selected Fracture, Osteotomy and Artrodesis Surgeries of the Foot and Ankle

The study in question is a post market clinical follow up (PMCF) study to evaluate the safety and performance of bioabsorbable headless compression screw Inion CompressOn in selected fracture, osteotomy and arthrodeses operations of the foot and ankle. The study recruits 125 adult patients who meet the acceptance criteria. The follow-up time for each study patient is 4 years. The study is a single center single group study which is conducted in Tampere University Hospital (TAYS) in Finland. The main focus of the study in terms of performance is to evaluate the bone healing/ossification of operated areas. The main focus of the study in terms of safety is to evaluate the occurrence of adverse events and required revision surgeries that are or might be related to the study device.

Study Overview

• Status: Recruiting
• Conditions: Fractures, Bone; Foot Deformities; Ankle Fractures; Hallux Valgus; Hallux Rigidus; Fracture of Foot; Lisfranc Fracture; Metatarsalgia; Lisfranc Injury; Deformity, Foot; Calcaneus Fracture; Talus Fracture; Medial Malleolus Fracture; Navicular Fracture; Foot Fracture; Foot Injury; Feet Deformity Tarsus; Deformity of Toe; Deformity of Foot
• Intervention / Treatment: Procedure: Operation

Detailed Description

The study in question is a post market clinical follow-up study to evaluate the safety and performance of bioabsorbable headless compression screw Inion CompressOn in selected fracture, osteotomy and arthrodeses operations of the foot and ankle. The main focus of the study in terms of performance is to evaluate the bone healing/ossification of operated areas. The main focus of the study in terms of safety is to evaluate the occurrence of adverse events and required revision surgeries that are or might be related to the study device.

The Inion CompressOn™ screws are cannulated headless compression screws made of degradable co-polymers composed of L-lactic acid and D-lactic acid. These polymers have a long history of safe medical use and they degrade in vivo by hydrolysis into alpha-hydroxy acids that are metabolised by the body. The screws retain their initial strength up to 12 weeks after implantation and gradually lose their strength thereafter. Bioabsorption takes place within two to four years. The Inion CompressOn™ products are intended for maintenance of alignment and fixation of bone fractures, comminuted fractures, osteotomies, arthrodeses or bone grafts (i.e., autografts or allografts) in the presence of appropriate additional immobilization (e.g., rigid fixation implants, cast or brace).

In the field of foot and ankle traumatology the surgical indications of this study include medial malleolar fractures, Lisfranc injuries, talus fractures, calcaneal fractures and navicular bone fractures. In the field of foot and ankle orthopaedics the surgical indications of the study include arthrodesis of the talonavicular joint, calcaneacuboideal joint, tarsometatarsal joint and first metatarsophalangeal (MTP1) joint, and osteotomies of the first metatarsal bone, second metatarsal bone (weil) and calcaneal bone.

The clinical data collection acquired from this study is a requirement of the EU Notified Body as part of the admitted CE mark certification, in cases when the device is initially approved based on the clinical data of an equivalent device. In this case, the equivalent device has been Inion FreedomScrew, which is made of the same material composition and has the same indications for use. Inion CompressOn Screw has new design features such as headless design, and threading which allows compression to the fracture line. Also new sizes are introduced.

The study recruits 125 adult patients who meet the acceptance criteria and have signed the informed consent. The follow-up time for each study patient is 4 years. Each patient has 6 follow-up time points related to the study. These time points consist of:

1. screening visit (-180-0 days before operation),
2. operation (day 0),
3. post-operative follow-up 1 (6 weeks after operation +/- 1 week),
4. post-operative follow-up 2 (3 months after operation +/- 2 weeks),
5. post-operative follow-up 3 (2 years after operation +/- 2 months)
6. post-operative follow-up 4 (4 years after operation +/- 4 months) The first 4 time points are within standard care, the last 2 time points (post-operative follow-up 3 and post-operative follow-up 4) are scheduled for study purposes only to be able to gain performance and safety data based on adequate follow-up time.

The study is a single center single group study which is conducted in Tampere University Hospital (TAYS) in Finland.

• Study Type: Interventional
• Enrollment (Anticipated): 125
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marika Manni, MD; Phone Number: +358 50 366 9994; Email: marika.manni@inion.com
• Study Contact Backup: Name: Kati Marttinen; Phone Number: +358 40 841 6217; Email: kati.marttinen@inion.com

Study Locations

• Finland
  • Tampere, Finland, 33520
    • Recruiting
    • Tampere university Hospital
    • Contact: Heikki Mäenpää, MD; Phone Number: +358 3 311 611; Email: heikki.maenpaa@pshp.fi
    • Sub-Investigator: Nikke Partio, MD
    • Sub-Investigator: Outi Päiväniemi, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Read the patient information bulletin on the study and signed the patient consent form
2. Adult patient (over 18-year-old)
3. Suitable and in need for surgical lower limb operation listed in the indications of this study that requires fastening of bone structures with screws (or an alternative attachment method) in the ankle or foot area, according to a statement of the investigator surgeon
4. Ability to fill in questionnaires.
5. Willingness to comply with rehabilitation instructions.
6. Availability for follow-up visits.

Exclusion Criteria:

1. Active infection
2. Patient conditions including limited blood supply (e.g. patients with severe circulatory disorder of the lower limb
3. Patient conditions including insufficient quality or quantity of bone (diagnosed osteoporosis, conditions causing secondary osteoporosis e.g. diabetes, rheumatism, eating disorder)
4. Patient conditions where patient cooperation cannot be guaranteed (alcohol use, drug abuse etc.)
5. High-load bearing indications (e.g., diaphyseal fractures of long bones) unless used in conjunction with traditional rigid fixation
6. Patients with significant neuropathy
7. Pregnancy
8. Patients who refuse to participate
9. Lower limb tumor or metastasis
10. Complex Regional Pain Syndrome (CRPS) in operated foot

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CompressOn group; 125 participant patients undergoing bone fixation surgical operation specified in the study description. All bone fixation surgeries are performed using Inion CompressOn screws.	Procedure: Operation; Bone fixation operation in foot or ankle area using bioabsorbable headless screw/s

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bone healing (ossification) of the fracture, osteotomy and arthrodesis lines	X-ray evaluation of bone healing (ossification) of the fracture, osteotomy and arthrodesis lines	Change from operation to 4 years
Occurrence of adverse events (AEs)	Assessment of occurrence of adverse events (AE), such as non-union of bone, fixation failure, mechanical irritation and tissue reactions related to implant bioabsorption	During 4-year follow-up
Occurrence of revision surgeries	Assessment of occurrence of revision surgeries related to study device	During 4-year follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subjective functionality of the operated foot or ankle (VAS foot and ankle)	Evaluation of subjective pain of the operated foot or ankle during follow-up	Change from baseline to 4 years
Subjective functionality of the operated foot or ankle (EFAS)	Evaluation of subjective functionality of the operated foot or ankle during follow-up	Change from baseline to 4 years
Wound and soft tissue healing	Assessment of post-operative complications (wound and soft tissue healing based on inspection and palpation)	Change from operation to 3 months
Fixation strength	X-ray evaluation of the maintaining of fixation position	Change from operation to 4 years
Bone formation in screw tunnel	X-ray evaluation of the level of bone formation in screw tunnel	Change from operation to 4 years

Collaborators and Investigators

• Sponsor: Inion Oy
• Investigators: Principal Investigator: Mäenpää, Tampere university Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 28, 2022
• Primary Completion (Anticipated): August 31, 2028
• Study Completion (Anticipated): November 30, 2028

Study Registration Dates

• First Submitted: September 8, 2022
• First Submitted That Met QC Criteria: September 22, 2022
• First Posted (Actual): September 26, 2022

Study Record Updates

• Last Update Posted (Actual): October 3, 2022
• Last Update Submitted That Met QC Criteria: September 30, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: arthrodesis; osteotomy; bioabsorbable screw; biodegradable; compression screw; headless screw; orthopaedic screw; bone fixation; bioabsorbable screw study; resorbable; bioabsorbable; fracture fixation with resorbable implants; inion; post-market follow-up study; orthopedic bone fixation
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Leg Injuries; Foot Diseases; Joint Diseases; Musculoskeletal Diseases; Musculoskeletal Abnormalities; Limb Deformities, Congenital; Foot Deformities, Acquired; Lower Extremity Deformities, Congenital; Wounds and Injuries; Congenital Abnormalities; Fractures, Bone; Ankle Fractures; Hallux Valgus; Hallux Rigidus; Foot Injuries; Foot Deformities; Foot Deformities, Congenital; Metatarsalgia
• Other Study ID Numbers: CompressOn1-2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No