Zone 2 Flexor Tendon Repair With CoNextions TR Implant System

NCT03622372 | Active Not Recruiting Phase 3 DMC FDA Device

• 1 other identifier: TRFDP1
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 4

Brief Summary

Prospective, randomised, controlled trial of a novel implant intended for use during surgical repair of lacerated Zone 2 flexor digitorum profundus tendons.

Conditions

Tendon Injury - Hand

Keywords

FLEXOR TENDON; ZONE 2

Outcome Measures

Primary Outcomes (2)

• Rate of tendon re-rupture

  Primary Safety Endpoint

  24 weeks

• Mobility of the affected digits using Strickland's Revised Score

  Primary Effectiveness Endpoint-Strickland's Revised Score provides a descriptive measure of the mobility of digits. Range of motion measurements taken on the studied digits are used to generate a score on a 0 (least mobile) to 100 (most mobile) with outcomes being classified as: excellent (75-100%), good (50-784%), fair (25-49%), or poor (\<25%).

  24 weeks

Secondary Outcomes (5)

• Visual Analog Score (VAS) for Pain Assessment (0-10 cm scale)

  24 weeks

• Surgical Site Infection

  24 weeks

• Disabilities of the Arm, Shoulder and Hand Questionnaire (DASH) Questionnaire

  24 weeks

• Grip Strength measured using a dynamometer with values for the affected hand being calculated as a percentage of the grip strength of the unaffected hand

  24 weeks

• Tip pinch strength measured with a pinch gauge with values for the affected fingers calculated as a percentage of the tip pinch strength for corresponding fingers on the unaffected hand

  24 weeks

Study Arms (2)

CoNextions TR Implant

EXPERIMENTAL

Operative repair of Zone 2 FDP tendon lacerations will be performed using the CoNextions TR Implant System

Procedure: Operative repair of Zone 2 FDP tendon lacerations; Device: CoNextions TR Implant System

Suture Repair

ACTIVE COMPARATOR

Operative repair of Zone 2 FDP tendon lacerations will be performed using a 4-strand locked cruciate repair utilizing either 3.0 or 4.0 prolene suture

Procedure: Operative repair of Zone 2 FDP tendon lacerations; Device: 4-strand locked cruciate repair

Interventions

Operative repair of Zone 2 FDP tendon lacerations PROCEDURE

Zone 2 tendon laceration(s) will be surgically repaired either using the experimental device or the active comparator

CoNextions TR Implant; Suture Repair

CoNextions TR Implant System DEVICE

The CoNextions TR Implant System will be used to repair Zone 2 FDP tendon laceration(s).

CoNextions TR Implant

4-strand locked cruciate repair DEVICE

A 4-strand locked cruciate repair utilizing either 3.0 or 4.0 prolene suture will be used to repair Zone 2 FDP tendon laceration(s).

Suture Repair

Eligibility Criteria

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

You may qualify if:

• At least 18 years of age
• Willing and able to provide a signed and dated informed consent form
• Stated willingness to comply with all study procedures
• Available for the duration of the study
• Have one or two fully lacerated digital FDP tendon(s), with or without a concomitant injury of the flexor digitorum superficialis, in Zone 2 of the index, middle, ring, or small finger
• Tendon laceration occurred within the previous 14 days

You may not qualify if:

• Pregnant or planning to become pregnant during the follow-up period
• Autoimmune disorder(s)
• Type 1 diabetes mellitus or clinical history of poorly controlled Type 2 diabetes mellitus
• Lack of proper cutaneous coverage at repair site
• Concomitant fracture
• Amputated digit(s)
• Arthritis of the hand
• Prior hand trauma with residual impact to function
• Congenital hand defect
• Conditions that would affect comparative measurements in the uninjured hand
• Tendon laceration caused by a crush injury
• Prior sensory impairment in digits of either hand. Note: Participants with nerve injuries associated with the trauma causing the current flexor tendon injury are eligible for enrollment
• Vascular injuries that require revascularisation procedures
• Ischemia and/or blood supply compromise
• Prior or current infections at or near the intended implant site

Sponsors & Collaborators

• CoNextions Medical: lead

Study Sites (4)

Grootte Schuur Hospital

Cape Town, South Africa

Location

Tygerberg Hospital

Cape Town, South Africa

Location

Inkosi Albert Luthuli Central Hosptial

Durban, South Africa

Location

Chris Hani Baragwanath Academic Hosptial

Soweto, South Africa

Location

Study Officials

• Michael Solomons, MD

  Grootte Schuur Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants and the Occupational Therapist performing the majority of the outcome assessments will be masked to the treatment until the 12 week post-operative visit.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Participants will be assigned using a 1:1 randomization scheme to receive either the investigational device or a suture repair for the surgical treatment of their tendon lacerations.

Study Record Dates

• First Submitted: July 18, 2018
• First Posted: August 9, 2018
• Study Start: June 21, 2018
• Primary Completion: June 20, 2020
• Study Completion: December 1, 2020
• Last Updated: November 3, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

ZA (4)