Arthroscopic Versus Open Subtalar Arthrodesis for the Treatment of Subtalar Arthritis

NCT07486596 | Active Not Recruiting DMC

• 1 other identifier: MD-482-2023
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to compare two surgical approaches for treating symptomatic subtalar arthritis in patients who have failed conservative treatment. The main questions it aims to answer are: What is the fusion rate for each surgical technique? Which technique achieves bony union faster with fewer complications? Researchers will compare arthroscopic subtalar arthrodesis (ASTA) using a combined three-to-four portal approach to open in situ subtalar arthrodesis (ISTA) to see if one technique results in superior fusion rates, faster healing, and better functional outcomes. Participants will: Undergo one of two surgical procedures (either ASTA or ISTA) Attend follow-up visits at 6 weeks, 3 months, 6 months, and 12 months after surgery Have X-rays taken to assess fusion and bone healing Complete pain and function questionnaires at each visit

Conditions

Subtalar Arthritis

Outcome Measures

Primary Outcomes (2)

• Fusion Rate at 6 months

  Fusion rate is defined as the proportion of patients achieving successful solid bony union of the subtalar joint. Union is determined using combined clinical and radiographic criteria, including absence of pain on palpation and passive stress, absence of detectable subtalar motion, and presence of continuous trabecular bridging across the posterior facet on plain radiographs or computed tomography when radiographs are inconclusive.

  6 months postoperatively

• Time to Radiographic Union

  Time to radiographic union is defined as the time elapsed from the date of surgery to the first radiographic evidence of continuous trabecular bridging across the subtalar joint fusion interface. Assessment is performed using serial plain radiographs, with computed tomography utilized when findings are equivocal.

  Up to 12 months postoperatively

Secondary Outcomes (4)

• Change in American Orthopaedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot Score

  Preoperative baseline, 6 months postoperatively, and 12 months postoperatively

• Change in Pain Intensity Measured by Visual Analog Scale (VAS)

  Preoperative baseline, 6 weeks, 3 months, 6 months, 12 months postoperatively

• Change in Short Form-12 (SF-12) Health Survey Scores

  Preoperative baseline, 6 months postoperatively, 12 months postoperatively

• Complication Rate

  Intraoperative through 12 months postoperatively

Study Arms (2)

Arthroscopic Subtalar Arthrodesis (ASTA)

ACTIVE COMPARATOR

Arthroscopic technique using a 4 mm 30° arthroscope in the prone position with a combined three-to-four portal approach (anterolateral sinus tarsi portal, posterolateral portal, posteromedial portal). Includes complete synovectomy, motorized debridement of posterior facet cartilage, subchondral microfracture drilling, and percutaneous screw fixation (two 6.5-7.3 mm cannulated screws) under fluoroscopic guidance.

Procedure: Arthroscopic Subtalar Arthrodesis

Open In Situ Subtalar Arthrodesis (ISTA)

EXPERIMENTAL

Open in situ subtalar arthrodesis via the lateral sinus tarsi approach performed in the supine position. All residual articular cartilage is removed to bleeding cancellous bone. The subchondral plate is perforated to enhance fusion. Fixation is achieved with two percutaneously inserted cannulated screws under fluoroscopic guidance.

Procedure: Open In Situ Subtalar Arthrodesis

Interventions

Arthroscopic Subtalar Arthrodesis PROCEDURE

Arthroscopic technique using a 4 mm 30° arthroscope in the prone position with a combined three-to-four portal approach (anterolateral sinus tarsi portal, posterolateral portal, posteromedial portal). Includes complete synovectomy, motorized debridement of posterior facet cartilage, subchondral microfracture drilling, and percutaneous screw fixation (two 6.5-7.3 mm cannulated screws) under fluoroscopic guidance.

Also known as: ASTA

Arthroscopic Subtalar Arthrodesis (ASTA)

Open In Situ Subtalar Arthrodesis PROCEDURE

Lateral sinus tarsi approach performed supine with 4-5 cm oblique incision. Complete cartilage debridement to bleeding cancellous bone, subchondral plate perforation, and percutaneous screw fixation (two cannulated screws) under fluoroscopic guidance.

Also known as: ISTA

Open In Situ Subtalar Arthrodesis (ISTA)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinically and radiographically confirmed symptomatic subtalar arthritis (post-traumatic, primary osteoarthritis, inflammatory or cured post-infective arthritis, symptomatic talocalcaneal coalition, or isolated subtalar arthrosis secondary to pes planovalgus deformity)
• Failure of an adequate trial of non-operative treatment for a minimum of six months
• Skeletal maturity: patients aged 18 years or older
• Ability and willingness to provide written informed consent and to comply fully with the scheduled postoperative follow-up protocol

You may not qualify if:

• Primary subtalar arthrodesis performed for an acute, displaced intra-articular calcaneal fracture
• Arthrodesis planned in conjunction with other simultaneous ipsilateral hindfoot procedures
• Patients with open physes (skeletal immaturity)
• Indication for a distraction-type arthrodesis requiring structural bone graft
• History of previous or current active infection at the planned operative site
• Previous failed attempt at subtalar arthrodesis
• Presence of significant peripheral vascular disease or other major medical comorbidities precluding safe surgical intervention

Sponsors & Collaborators

• Cairo University: lead
• Kasr El Aini Hospital: collaborator

Study Sites (1)

Cairo university hospitals

Cairo, Cairo Governorate, 4240310, Egypt

Location

Study Officials

• Helal Hosny Abdulaziz, M.B., B.Ch., M.Sc.

  Cairo University

  PRINCIPAL INVESTIGATOR

• Ahmed Samir Bashandy

  Cairo University

  STUDY CHAIR

• Ahmed Mohamed Khedr

  Cairo University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Due to the inherent nature of the surgical interventions, blinding of the patients and the primary surgeon was not feasible. However, the assessor responsible for collecting postoperative outcome scores was kept blinded to group assignment to minimize detection bias.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Orthopaedic Surgery Specialist (Doctoral Candidate)

Study Record Dates

• First Submitted: March 14, 2026
• First Posted: March 20, 2026
• Study Start: December 5, 2023
• Primary Completion: April 1, 2026
• Study Completion: June 1, 2026
• Last Updated: April 13, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)