Evaluation of the Treatment of Arthritis and the Correction of Bone Alignment Default of the Toes Using the Lync® Medical Device

Status: Recruiting
Location: See all (5) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The LYNC clinical investigation aims to confirm the clinical benefits, performance and safety of the Lync® device when implanted in the toes for the treatment of arthritis and correction of bone misalignments. The main objective of the study is to confirm the clinical benefits of the Lync® device for the treatment of arthritis and the correction of bone alignment default, by evaluating the restoration of the functional capacities of the forefoot at 3 -4 months post-operative follow-up with AOFAS-LMIS score.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Patient requiring treatment of arthritis and/or correction of bone alignement defaultin the toes (mallet toes, claw toes, hammer toes),

• Use of the Lync® intramedullary osteosynthesis implantable medical device,

• No associated surgical procedures except:▪Flexor release/tenotomy

‣ MTP Arthrolysis / Extensor Lengthening

⁃ Tendon transfers

⁃ Phalangeal osteotomy

• Adult patient,

• Patient capable of respecting the prescriptions and recommendations of his surgeon,

• Patient able to read and understand the information note and the consent form,

• Patient able to sign a consent form.

Locations
Other Locations
France
Clinique Saint-Charles
RECRUITING
Lyon
Polyclinique du Val de Saône
RECRUITING
Mâcon
Centre Chirurgical ADR
NOT_YET_RECRUITING
Nancy
Clinique Mutualiste Catalane
RECRUITING
Perpignan
Polyclinique Lyon Nord
RECRUITING
Rillieux-la-pape
Contact Information
Primary
Manon GUIGUEN
manon.guiguen@novastep-ortho.com
+33 (0) 2 59 58 31 68
Backup
Flora PEYRET
flora.peyret@novastep-ortho.com
+33 (0) 2 59 58 31 68
Time Frame
Start Date: 2024-11-04
Estimated Completion Date: 2027-05-01
Participants
Target number of participants: 76
Treatments
Experimental: Intervention with Lync device
One arm in the study : treatment of arthritis and/or correction of bone alignement default in the toes (mallet toes, claw toes, hammer toes) wwith Lync device.
Related Therapeutic Areas
Sponsors
Leads: Novastep

This content was sourced from clinicaltrials.gov