Tendon Injury - HandPhase 3NCT03622372
Zone 2 Flexor Tendon Repair With CoNextions TR Implant System
A Phase 3 study testing Operative repair of Zone 2 FDP tendon lacerations, CoNextions TR Implant System and 4-strand locked cruciate repair in people with Tendon Injury - Hand, run by CoNextions Medical at 4 sites in South Africa.
Trial summary
Prospective, randomised, controlled trial of a novel implant intended for use during surgical repair of lacerated Zone 2 flexor digitorum profundus tendons. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tendon Injury - Hand
- What is being tested?
- Operative repair of Zone 2 FDP tendon lacerations, CoNextions TR Implant System and 4-strand locked cruciate repair
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 4 sitesSouth Africa
- Study dates
- 21 Jun 2018to Dec 2020
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 23Show fewer
- 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.
Trial locations and contacts
4 sites in 1 country.
South Africa4 sites
Grootte Schuur Hospital
Cape Town
Tygerberg Hospital
Cape Town
Inkosi Albert Luthuli Central Hosptial
Durban
Chris Hani Baragwanath Academic Hosptial
Soweto
About this study
Official title: Pivotal, Randomised, Controlled Trial to Evaluate the Safety and Effectiveness of the CoNextions TR Implant System for Zone 2 Flexor Tendon Repair
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
- Being tested
- Operative repair of Zone 2 FDP tendon lacerations, CoNextions TR Implant System, 4-strand locked cruciate repair
- Keywords
- FLEXOR TENDON, ZONE 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Operative repair of Zone 2 FDP tendon lacerationsProcedure or surgery
Zone 2 tendon laceration(s) will be surgically repaired either using the experimental device or the active comparator
CoNextions TR Implant SystemDevice
The CoNextions TR Implant System will be used to repair Zone 2 FDP tendon laceration(s).
4-strand locked cruciate repairDevice
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).
| Study group | Role | What they receive |
|---|---|---|
| CoNextions TR Implant | Experimental | Operative repair of Zone 2 FDP tendon lacerations will be performed using the CoNextions TR Implant System Receives: 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 Receives: Procedure: Operative repair of Zone 2 FDP tendon lacerations; Device: 4-strand locked cruciate repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of tendon re-rupture
Primary Safety Endpoint
Measured: 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%).
Measured: 24 weeks
Secondary outcomes (5)
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).
Measured: 24 weeks
Surgical Site Infection
Presence of infection at the surgical site
Measured: 24 weeks
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.
Measured: 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
The average of three grip strength values taken in succession (kilograms).
Measured: 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
The average of three tip pinch strength values taken in succession (kilograms).
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2018
- Study start21 Jun 2018
- Primary completion20 Jun 2020
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tendon Injury - HandStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- CoNextions Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Solomons, MD, Principal investigator, Grootte Schuur Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03622372
- Sponsor's protocol ID
- TRFDP1
- Status last verified
- Nov 2020
- First submitted
- 18 Jul 2018
- Last updated
- 3 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pivotal, Randomised, Controlled Trial to Evaluate the Safety and Effectiveness of the CoNextions TR Implant System for Zone 2 Flexor Tendon Repair
- ClinicalTrials.gov ID
- NCT03622372
- Acronym / sponsor ID
- TRFDP1
- Conditions
- Tendon Injury - Hand
- Keywords
- FLEXOR TENDON, ZONE 2
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 90 participants (actual)
- Lead sponsor
- CoNextions MedicalIndustry (pharma, biotech, devices)
- Study start
- 21 Jun 2018 (actual)
- Primary completion
- 20 Jun 2020 (actual)
- Study completion
- Dec 2020 (estimated)
- First posted
- 9 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Prospective, randomised, controlled trial of a novel implant intended for use during surgical repair of lacerated Zone 2 flexor digitorum profundus tendons.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| CoNextions TR Implant | Experimental | Procedure: Operative repair of Zone 2 FDP tendon lacerations, Device: CoNextions TR Implant SystemOperative repair of Zone 2 FDP tendon lacerations will be performed using the CoNextions TR Implant System |
| Suture Repair | Active comparator | Procedure: Operative repair of Zone 2 FDP tendon lacerations, Device: 4-strand locked cruciate repairOperative 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (23 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Operative repair of Zone 2 FDP tendon lacerationsZone 2 tendon laceration(s) will be surgically repaired either using the experimental device or the active comparator | Procedure or surgery | CoNextions TR Implant, Suture Repair |
| CoNextions TR Implant SystemThe CoNextions TR Implant System will be used to repair Zone 2 FDP tendon laceration(s). | Device | CoNextions TR Implant |
| 4-strand locked cruciate repairA 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). | Device | Suture Repair |
Primary outcome
Rate of tendon re-rupture
Time frame: 24 weeks
Primary Safety Endpoint
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%).
5 secondary outcomes
Visual Analog Score (VAS) for Pain Assessment (0-10 cm scale)
Time frame: 24 weeks
Surgical Site Infection
Time frame: 24 weeks
Disabilities of the Arm, Shoulder and Hand Questionnaire (DASH) Questionnaire
Time frame: 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
Time frame: 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
Time frame: 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Solomons, MD principal investigator
Grootte Schuur Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Operative repair of Zone 2 FDP tendon lacerations, CoNextions TR Implant System and 4-strand locked cruciate repair in people with Tendon Injury - Hand, run by CoNextions Medical at 4 sites in South Africa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 3 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of tendon re-rupture (time frame: 24 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2020.