Medial Displacement Calcaneal Osteotomy and FDL- Transfer - With a Human, Allogeneic Cortical Bone Screw
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorOrthopedic Hospital Vienna Speising
About this trial
The goal of this observational study is to compare the use of a screw made of human bone (Shark-Screw®, Surgebright-GmbH) with the metal/Bio-Tenodesis screw (Arthrex) in the treatment of the symptomatic flatfoot using the medializing calcaneus osteotomy with flexor digitorum longus transfer (FDL) in adult patients. The advantage of the human bone screw is that after surgery no hardware removal is necessary. The screw is transformed from the body to normal bone.
The main questions it aims to answer are:
* Can the human bone screw achieve union rates like the metal/Bio-Tenodesis screw? * Is the time to union similar between the different screws? * Is the complication rate similar between the different screws? * Are the activity scores American Orthopaedic Foot and Ankle Society (AOFAS), Foot and Ankle Outcome Score (FAOS) and Foot Function Index (FFI) after surgery similar in the compared patient groups?
Participants will have
* the surgery * follow-ups at 6 weeks, 6 months, 1 and 2 years. * X-rays are performed at each follow up. * CT-scans are performed after 6 months. * activity scores are collected at the follow up after 6 months, 1 year and 2 years.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Indication for the use of a metal/Bio-Tenodesis screw or human bone screw in medializing calcaneus osteotomy with FDL transfer.
BMI< 40 kg/m²
Disqualifiers
Insufficient knowledge of German
Alcohol and drug abuse
Pregnant woman or nursing mother
Foreseeable compliance problems
Trial population
adult patients with an indication for the use of a metal/Bio-Tenodesis screw or human bone screw in medializing calcaneus osteotomy with/without FDL transfer. The patient has the choice of the treatment method after explanation advantages and disadvantages for each surgery method
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
medializing calcaneal osteotomy and/or transfer of the flexor digitorum longus tendon (FDL) with metal/Bio-Tenodesis screws
Procedure/SurgeryThe calcaneus osteotomy is performed dorsal proximal to plantar distal with caution of the peroneal tendons and sural nerve. After mobilization the dorsal fragment is displaced medially by\~10mm. Thereafter, a guide wire is placed from plantar-lateral into the ventral portion of the calcaneus under fluoroscopic control. After stab incision and length measurement, the osteotomy is fixed with a Metal/Bio-Tenodesis screw(MBS). The lateral projection of the edge is straightened. Opening of the tendon sheath of the FDL muscle and dissection distally to Henry's node. Settling of the tendon and arming with a "shuttle suture". Tendon diameter measurement. Place a guide wire at os naviculare directed from plantar to dorsal in 20°proximal guidance. Pull through the FDL tendon from plantar to dorsal and fixation with an MBS in 20°of pointed foot position and inversion with appropriate desired tension. The tendon is then sutured to the stump of the tibialis posterior tendon, retinaculum sutures.
medializing calcaneal osteotomy and/or transfer of the flexor digitorum longus tendon (FDL) with Shark Screws®
Procedure/SurgeryThe calcaneus osteotomy is performed dorsal proximal to plantar distal with caution of the peroneal tendons and sural nerve. After mobilization the dorsal fragment is displaced medially by approx.10mm. Thereafter, a guide wire is placed from plantar-lateral into the ventral portion of the calcaneus under fluoroscopic control. After stab incision and length measurement, the osteotomy is fixed with a Shark Screw®. The lateral projection of the edge is straightened. Opening of the tendon sheath of the FDL muscle and dissection distally to Henry's node. Settling of the tendon and arming with a "shuttle suture". Tendon diameter measurement. Place a guide wire at os naviculare directed from plantar to dorsal in 20°proximal guidance. Pull through the FDL tendon from plantar to dorsal and fixation with the Shark Screw® in 20°of pointed foot position and inversion with appropriate desired tension. The tendon is then sutured to the stump of the tibialis posterior tendon, retinaculum sutures.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: metal/Bio-Tenodesis group1 intervention
Group B: human, allogeneic cortical bone screw (Shark Screw®)1 intervention
Trial outcomes
Primary outcomes
1
x-ray qualitative evaluation of changes in bony union of calcaneus osteotomy
bony union will be evaluated
Time frame
6 weeks, 6 months, 1 year, 2 years2
CT-scan qualitative evaluation of changes in bony union of calcaneus osteotomy
bony union will be evaluated
Time frame
6 months, 1 yearSecondary outcomes
1
changes in AOFAS score in comparison to presurgery
The American Orthopedic Foot and Ankle Score (AOFAS) units in percent (%), the higher the better
Time frame
6 months, 1 year and 2 years2
changes in Foot and Ankle Outcome Score (FOAS) score in comparison to presurgery
Foot and Ankle Outcome Score units in percent (%), the higher the better
Time frame
6 months, 1 year and 2 years3
changes in FFI score in comparison to presurgery
Foot Function Index units in percent (%), the higher the better
Time frame
6 months, 1 year and 2 years4
changes in Vas-Pain score in comparison to presurgery
Visual Analog Scale Pain Score values between 0 and 10, 0= no pain, 10 sever pain
Time frame
6 weeks, 6 months, 1 year and 2 yearsSponsors and contacts
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Source ClinicalTrials.gov