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NCT Number: NCT03622372

Zone 2 Flexor Tendon Repair With CoNextions TR Implant System

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

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Tendon Injury - Hand

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Grootte Schuur Hospital, Cape Town, South Africa

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • Active sepsis, MRSA, or other conditions that may prevent healing
  • History of foreign-body sensitivity to 316 L Stainless Steel or UHMWPE
  • Implantation of CoNextionsTR Implant would result in physical contact with other metal implants made of material other than implant grade stainless steel such as titanium, titanium alloys, cobalt chromium, or other dissimilar metals
  • Any condition(s) which, in the opinion of the investigator, may impact the participant's ability to properly follow-up or otherwise be at-risk for following protocol instructions
  • Currently participating in another clinical/device trial

The following criteria, determined during the surgical procedure, will also cause an individual to be excluded from the study:

  • Surgical site access less than 20 mm in total or less than 10 mm on either side of intended implant site
  • Injured tendon is outside of the width range (3.0-7.0 mm) and thickness range (1.5-4.0 mm) specified for the CoNextionsTR Implant System.

Treatment and study plan

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 System

Device

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

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).

Primary outcomes

  1. Rate of tendon re-rupture

    Time frame: 24 weeks

    Primary Safety Endpoint

  2. Mobility of the affected digits using Strickland's Revised Score

    Time frame: 24 weeks

    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%).

Secondary outcomes

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

    Time frame: 24 weeks

    Patient reported pain intensity measuring from 0 (no pain) to 10 (worst imaginable pain).

  2. Surgical Site Infection

    Time frame: 24 weeks

    Presence of infection at the surgical site

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

    Time frame: 24 weeks

    DASH is a patient-reported questionnaire consisting of 30 questions designed to evaluate a patients ability to perform certain upper extremity activities. The patients answers are used to calculate a score from 1 (most disabled) to 100 (least disabled). DASH is validated to be able to detect small and large changes over time, most notably before and after surgical interventions in the upper extremity.

  4. 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

    Time frame: 24 weeks

    The average of three grip strength values taken in succession (kilograms).

  5. 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

    Time frame: 24 weeks

    The average of three tip pinch strength values taken in succession (kilograms).

Sponsors and collaborators

Lead sponsor

CoNextions Medical

Industry

Registry information

Official study title

Pivotal, Randomised, Controlled Trial to Evaluate the Safety and Effectiveness of the CoNextions TR Implant System for Zone 2 Flexor Tendon Repair

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Aug 9, 2018
Registry last updated
Nov 3, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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