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Wires as an alternative to screws for bunion correction surgery: a randomized clinical trial.

Kirschner wires as an alternative to cannulated screws for hallux valgus correction using the minimally invasive chevron-Akin technique: a randomized clinical trial.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-107ynv85
Enrollment
Unknown
Registered
2021-11-08
Start date
2021-11-09
Completion date
Unknown
Last updated
2025-10-27

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

Conditions

Acquired deformities of the fingers and toes

Interventions

The procedures will be performed under spinal anesthesia (0.5% bupivacaine hydrochloride + 150 mcg clonidine + 0.1 mg morphine) and sedation (midazolam 5 mg). In addition, antibiotic prophylaxis will
19619
1888

Sponsors

Universidade Federal do Pará
Lead Sponsor
Hospital Maradei
Collaborator

Eligibility

Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: - Patients of both genders; - Patients undergoing minimally invasive surgery, using the chevron-Akin technique, for moderate or severe hallux valgus correction; - Patients without previous history of surgery for hallux valgus correction; - Patients who failed conservative treatment; - Absence of instability of the first tarsometatarsal joint, defined as abnormal painful movement; - Absence of osteoathritis of the metatarsophalangeal joint of the hallux; - Absence of concomitant deformities of the hindfoot and midfoot; - Absence of rheumatological and neurological diseases.

Exclusion criteria

Exclusion criteria: - Patients who do not attend their return appointments; - Participants who request their removal from the research by their own initiative; - Death due to a reason unrelated to the complication of surgery during the follow-up.

Design outcomes

Primary

MeasureTime frame
Deformity correction. Measured, on radiographs, by hallux valgus, intermetatarsal and distal articular angles, of the first metatarsal, preoperatively and postoperatively at 6 weeks, 6 months, 12 months and 24 months. Such assessment will be made by the executing researcher. There will be no blinding, since the professional will be able to see, through the radiographs, which group the patient belongs to.

Secondary

MeasureTime frame
Clinical outcomes. Measured by scoring the American Orthopedic Foot & Ankle Society questionnaire for hallux valgus, by responses to the visual analogue pain scale, and by asking about patient satisfaction. This assessment will be carried out by the responsible researcher preoperatively and postoperatively at 6 weeks, 6 months, 12 months and 24 months. In this evaluation there will be blinding, as the evaluator will not be able to identify which group the patient belongs to. ;Development of degenerative alterations. Measured by radiographs taken at 6 weeks, 6 months, 12 months and 24 months, according to the scale of Kellgren and Lawrence. This evaluation will be done by a certified orthopedist (who will not be the surgeon or involved in the patient's care) and there will be no blinding, as the professional will be able to see which group the patient belongs to, since the wires or screws are identifiable on the radiograph.

Countries

Brazil

Contacts

Public ContactMaria Clara;João Alberto da Silva;Pereira

;

mariaclarapinheirods@gmail.com;jamaradei@ufpa.br+55 (91) 99352-0126;+55 (91) 98889-0712

Outcome results

None listed

Source: REBEC (via WHO ICTRP)