Clinical Analysis of a Novel Flexor Tendon Repair Technique

Conditions

• Flexor Tendon Laceration

Eligibility Criteria

Sex

ALL

Age

22 Years - 88 Years

Healthy Volunteers

Not accepted

Study Details

The purpose of the research study is to determine the efficacy and efficiency of two tendon repair techniques: the CoNextions tendon repair device vs a standard of care, L-O (Lew-Omar), suture repair technique. The investigators will also determine if there are similar or different rates of complications and failures via both objective and subjective measures.

Key Dates

Start date

Jun 18, 2024

Status verified

Jul 2025

Primary completion

Jan 31, 2027

Completion

Jul 31, 2027

Study Design

Enrollment

128 participants (estimated)

Arms

• Arm: repair with the CoNextions tendon repair device
• Arm: repair with a "standard of care" repair technique known as the Lew-Omar (LO) technique

Primary Outcome Measure

To determine the tendon failure/rupture rate of two tendon repair techniques: the CoNextions tendon repair device vs a standard of care suture repair technique. Also to determine if there are similar or different rates of complications and failures [ Time Frame: From enrollment to end of postoperative follow up at 6-months. ]

Central Contacts

• Brett Lewellyn, MD
  321-843-5851
  [email protected]

Locations (1)

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