Management of Intractable Plantar Fasciitis by Plantar Fascia Release Compared With Plantar Displacement Calcaneal Osteotomy: Randomized Control Study
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 主要终点
- the change in the American Orthopaedic Foot and Ankle Society Ankle Hindfoot Scale (AOFAS score)
研究概览
简要总结
The aim of this study is to clarify the efficacy of plantar displacement calcaneal osteotomy for intractable plantar fasciitis by decreasing the tension of the plantar fascia around the calcaneal attachment while keeping the plantar fascia intact and comparing it with the plantar fascia release in pain control, job return and foot arch preservation.
详细描述
Plantar fasciitis (PF) is the most common cause of heel pain accounting for 15% of all foot symptoms requiring medical care and 1% of patient visits to orthopaedic surgeons in the United states.
The diagnosis is straight forward; the challenge is finding an effective and economic first line treatment. The annual costs of plantar fasciitis are $284 million, that does not include opportunity cost from lost work and wages, societal burden, and psychologic burden.
Histologic examination shows myxoid degeneration with fragmentation and degeneration of the plantar fascia and supports being a degenerative fasciitis without inflammation. Therefore, plantar fasciopathy is a more accurate descriptor.
Treatment is largely nonoperative, with 85% to 90% of patients experiencing resolution of symptoms within 6-12 months. Partial or complete plantar fasciotomy, either open or endoscopic is indicated only for intractable cases with failed conservative treatment.
Fascia release, being the main surgery, sometimes accompanied by complications, one of which is lateral column pain due to loss of the longitudinal arch height caused by the release of the plantar fascia with no consensus regarding the amount of the plantar fascia which should be released in order to relieve pain without causing lateral column pain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Each patient will be randomly assigned to his group using quick Calcs methodfor randomization (https://www.graphpad.com/quickcalcs/randomize1/) either group A (plantar fascia open release) or group B (Plantar fascia endoscopic release) or group C( calcaneal osteotomy)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All adult patients with age range from 18 to 65 years with unilateral or bilateral PF after clinical and radiological diagnosis confirmation, who had failed conservative treatment for at least 6 months or recurrent cases after steroid injection
排除标准
- •All other causes of heel pain including seronegative arthropathies, rheumatoid arthritis in bilateral cases, abscess or neoplasm affecting the soft tissue, and bone occult fracture or infection.
- •age groups below 18 years old and above 65 years old.
- •Plantar fasciitis cases with pes planus.
研究组 & 干预措施
plantar fascia release
plantar fascia open release Longitudinal incision at the medial heel, Exposure of the plantar fascia at its origin on the medial plantar calcaneus. Medial incision of the plantar fascia preserving the lateral portion.. Exposure of the abductor hallucis muscle. Incision of the superficial fascia of the muscle. Retraction of the muscle belly und incision of the deep portion of the fascia, decompression of the first calcaneal branch of the lateral plantar nerve (Baxter's nerve) in cases of its being compressed.
Postoperative management: Two weeks partial weight bearing. Progressively weight bearing using a shoe with a stiff sole for another 4 weeks.
干预措施: plantar fascia open release (Procedure)
Plantar fascia endoscopic release
We will draw a line distally from the posterior aspect of the medial malleolus to the intersection of the medial origin of the plantar fascia at the calcaneal tuberosity. A skin incision will be made, and medial portal will be performed at this location. Blunt dissection will be performed to clear the subcutaneous tissue from the plantar fascia with caution to avoid lesion of the calcaneal nerve medial branch.
干预措施: plantar fascia endoscopic release (Procedure)
Clacaneal osteotomy
calcaneal osteotomy skin incision will be oblique and directed from the inferoposterior edge of the lateral malleolus to the inferior edge of the calcaneal body, and subperiosteal exposure of the lateral calcaneal wall will be performed. Osteotomy will be performed from 1 cm anterior of the calcaneal attachment of the plantar fascia to 1 cm anterior of the calcaneal attachment of the Achilles tendon. After the osteotomy, approximately 5 mm plantar displacement of the proximal fragment, which include attachment of the plantar fascia, will be performed. Fixation after the osteotomy will be performed under an image intensifier using one cannulated cancellous screws 4.5 mm in diameter, which will be inserted from the infero-medial of the calcaneal tuberosity to the distal fragment
干预措施: calcaneal osteotomy for intractable plantar fasciitis (Procedure)
结局指标
主要结局
the change in the American Orthopaedic Foot and Ankle Society Ankle Hindfoot Scale (AOFAS score)
时间窗: 6 months after surgery
score of 100 points.higher score means better function with less pain and good alignment
次要结局
未报告次要终点
研究者
El-Taher Alaa Eldin Ahmed Eid
principle investigator
Assiut University