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Zone 2 Flexor Tendon Repair With CoNextions TR Implant System

Primary Purpose

Tendon Injury - Hand

Status
Unknown status
Phase
Phase 3
Locations
South Africa
Study Type
Interventional
Intervention
Operative repair of Zone 2 FDP tendon lacerations
CoNextions TR Implant System
4-strand locked cruciate repair
Sponsored by
CoNextions Medical
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tendon Injury - Hand focused on measuring FLEXOR TENDON, ZONE 2

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. At least 18 years of age
  2. Willing and able to provide a signed and dated informed consent form
  3. Stated willingness to comply with all study procedures
  4. Available for the duration of the study
  5. 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
  6. Tendon laceration occurred within the previous 14 days

Exclusion Criteria:

  1. Pregnant or planning to become pregnant during the follow-up period
  2. Autoimmune disorder(s)
  3. Type 1 diabetes mellitus or clinical history of poorly controlled Type 2 diabetes mellitus
  4. Lack of proper cutaneous coverage at repair site
  5. Concomitant fracture
  6. Amputated digit(s)
  7. Arthritis of the hand
  8. Prior hand trauma with residual impact to function
  9. Congenital hand defect
  10. Conditions that would affect comparative measurements in the uninjured hand
  11. Tendon laceration caused by a crush injury
  12. 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
  13. Vascular injuries that require revascularisation procedures
  14. Ischemia and/or blood supply compromise
  15. Prior or current infections at or near the intended implant site
  16. Active sepsis, MRSA, or other conditions that may prevent healing
  17. History of foreign-body sensitivity to 316 L Stainless Steel or UHMWPE
  18. 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
  19. 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

  20. 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:

  21. Surgical site access less than 20 mm in total or less than 10 mm on either side of intended implant site
  22. 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.

Sites / Locations

  • Grootte Schuur Hospital
  • Tygerberg Hospital
  • Inkosi Albert Luthuli Central Hosptial
  • Chris Hani Baragwanath Academic Hosptial

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

CoNextions TR Implant

Suture Repair

Arm Description

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

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

Outcomes

Primary Outcome Measures

Rate of tendon re-rupture
Primary Safety Endpoint
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%).

Secondary Outcome Measures

Visual Analog Score (VAS) for Pain Assessment (0-10 cm scale)
Patient reported pain intensity measuring from 0 (no pain) to 10 (worst imaginable pain).
Surgical Site Infection
Presence of infection at the surgical site
Disabilities of the Arm, Shoulder and Hand Questionnaire (DASH) Questionnaire
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.
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
The average of three grip strength values taken in succession (kilograms).
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
The average of three tip pinch strength values taken in succession (kilograms).

Full Information

First Posted
July 18, 2018
Last Updated
November 1, 2020
Sponsor
CoNextions Medical
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1. Study Identification

Unique Protocol Identification Number
NCT03622372
Brief Title
Zone 2 Flexor Tendon Repair With CoNextions TR Implant System
Official Title
Pivotal, Randomised, Controlled Trial to Evaluate the Safety and Effectiveness of the CoNextions TR Implant System for Zone 2 Flexor Tendon Repair
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Unknown status
Study Start Date
June 21, 2018 (Actual)
Primary Completion Date
June 20, 2020 (Actual)
Study Completion Date
December 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CoNextions Medical

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tendon Injury - Hand
Keywords
FLEXOR TENDON, ZONE 2

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
ParticipantOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CoNextions TR Implant
Arm Type
Experimental
Arm Description
Operative repair of Zone 2 FDP tendon lacerations will be performed using the CoNextions TR Implant System
Arm Title
Suture Repair
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
Operative repair of Zone 2 FDP tendon lacerations
Intervention Description
Zone 2 tendon laceration(s) will be surgically repaired either using the experimental device or the active comparator
Intervention Type
Device
Intervention Name(s)
CoNextions TR Implant System
Intervention Description
The CoNextions TR Implant System will be used to repair Zone 2 FDP tendon laceration(s).
Intervention Type
Device
Intervention Name(s)
4-strand locked cruciate repair
Intervention Description
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 Outcome Measure Information:
Title
Rate of tendon re-rupture
Description
Primary Safety Endpoint
Time Frame
24 weeks
Title
Mobility of the affected digits using Strickland's Revised Score
Description
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%).
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Visual Analog Score (VAS) for Pain Assessment (0-10 cm scale)
Description
Patient reported pain intensity measuring from 0 (no pain) to 10 (worst imaginable pain).
Time Frame
24 weeks
Title
Surgical Site Infection
Description
Presence of infection at the surgical site
Time Frame
24 weeks
Title
Disabilities of the Arm, Shoulder and Hand Questionnaire (DASH) Questionnaire
Description
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.
Time Frame
24 weeks
Title
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
Description
The average of three grip strength values taken in succession (kilograms).
Time Frame
24 weeks
Title
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
Description
The average of three tip pinch strength values taken in succession (kilograms).
Time Frame
24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Solomons, MD
Organizational Affiliation
Grootte Schuur Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Grootte Schuur Hospital
City
Cape Town
Country
South Africa
Facility Name
Tygerberg Hospital
City
Cape Town
Country
South Africa
Facility Name
Inkosi Albert Luthuli Central Hosptial
City
Durban
Country
South Africa
Facility Name
Chris Hani Baragwanath Academic Hosptial
City
Soweto
Country
South Africa

12. IPD Sharing Statement

Plan to Share IPD
No

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Zone 2 Flexor Tendon Repair With CoNextions TR Implant System

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