Active — Not RecruitingPhase 3

Zone 2 Flexor Tendon Repair With CoNextions TR Implant System

South Africa90 participantsStarted 2018-06-21

Plain-language summary

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

Who can participate

Age range18 Years

SexALL

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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

What they're measuring

Rate of tendon re-rupture

Timeframe: 24 weeks

Mobility of the affected digits using Strickland's Revised Score

Timeframe: 24 weeks

Trial details

NCT IDNCT03622372

SponsorCoNextions Medical

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2020-06-20

View on ClinicalTrials.gov More Tendon Injury - Hand trials