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Prospective study comparing open versus arthroscopic subtalar arthrodesis

Prospective study comparing open versus arthroscopic subtalar arthrodesis - Open versus arthroscopic subtalar arthrodesis

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON45062
Enrollment
52
Registered
2013-07-08
Start date
2013-08-08
Completion date
Unknown
Last updated
2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

degenerative arthritis degenerative joint disease

Interventions

Open arthrodesis Open arthrodesis is a surgical procedure of the foot where an incision is made on the lateral side of the foot to gain access to the subtalar joint. The cartilage is removed as well

Sponsors

Sint Maartenskliniek
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. Isolated subtalar osteoarthritis 2. Diagnosis primary osteoarthritis or posttraumic osteoarthritis 3. 6 Months duration of symptoms 4. Age 18-80y 5. Less than 15 degrees valgus or 5 degrees varus of the subtalar joint

Exclusion criteria

Exclusion criteria: 1. Previous surgery of the subtalar joint 2. Osteonecrosis. 3. Rheumatoid arthritis, Complex Regional Pain Syndrom, neurological impairment

Design outcomes

Primary

MeasureTime frame
The main study parameter is the early complication rate after surgery. These early complications consist of wound healing disturbance caused by necrosis of the skin, superficial wound infection, deep wound infection, nerve damage caused by the skin incision, and tendon lacerations caused by the skin incision.

Secondary

MeasureTime frame
Secondary study parameters are the number of late complications (>=6 weeks), patient satisfaction, pain and function after arthrodesis. Apart from number of late complications, these parameters will be measured: preoperatively (excluding satisfaction), and after 3,6,12 months after surgery.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)