Tendon Injury - Hand
Conditions
Keywords
FLEXOR TENDON, ZONE 2
Brief summary
Prospective, randomised, controlled trial of a novel implant intended for use during surgical repair of lacerated Zone 2 flexor digitorum profundus tendons.
Interventions
PROCEDUREOperative repair of Zone 2 FDP tendon lacerations
Zone 2 tendon laceration(s) will be surgically repaired either using the experimental device or the active comparator
DEVICECoNextions TR Implant System
The CoNextions TR Implant System will be used to repair Zone 2 FDP tendon laceration(s).
DEVICE4-strand locked cruciate repair
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).
Sponsors
CoNextions Medical
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes 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.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of tendon re-rupture | 24 weeks | Primary Safety Endpoint |
| Mobility of the affected digits using Strickland's Revised Score | 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
| Measure | Time frame | Description |
|---|---|---|
| Disabilities of the Arm, Shoulder and Hand Questionnaire (DASH) Questionnaire | 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. |
| Surgical Site Infection | 24 weeks | Presence of infection at the surgical site |
| 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 | The average of three tip pinch strength values taken in succession (kilograms). |
| 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 | The average of three grip strength values taken in succession (kilograms). |
| Visual Analog Score (VAS) for Pain Assessment (0-10 cm scale) | 24 weeks | Patient reported pain intensity measuring from 0 (no pain) to 10 (worst imaginable pain). |
Countries
South Africa
Outcome results
None listed