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Arthroscopic surgery combined with postoperative shock wave therapy for treating osteochondral lesions of the talus

Arthroscopicsurgery combined with postoperative shock wave therapy for treating osteochondral lesions of the talus: A prospective, multicentre, randomised, double-blind clinical study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN82244069
Enrollment
32
Registered
2017-02-03
Start date
2017-02-01
Completion date
Unknown
Last updated
2017-02-27

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

Conditions

Osteochondral Lesions of the Talus, Hepple Phase ?-? Musculoskeletal Diseases Osteochondral Lesions of the Talus, Hepple Phase ?-?

Interventions

Patients who are diagnosed as Osteochondral Lesions of the Talus (OLT) at the outpatient department will be admitted to the hospital. The OLT will be treated with conventional arthroscopic surgery and
the energy density will be set at 0.18-0.25mJ / mm2. 2-3 treatment points will be chosen in each treatment
each point will receive shock wave for 1000 times, totaling 2000-3000 times. The treatment will be given on every other day. 1 course consists of 5 treatments, and the participants in the experimental
as well as MRI imaging at pre-operatively, and 3, 12 months post-operatively.

Sponsors

Southwest Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Age 18 years or more and less than 80 years (including 80 years) 2. The disease lasts for more than 6 months; symptoms still remain after drug treatment 3. MRI suggests the diagnosis of Hepple Phase-? Osteochondral Lesions of the Talus 4. The AOFAS score is lower than 75 after 10-12 weeks of ankle arthroscopy 5. Patients who sign the informed consent, agree to participant in the study and cooperate during the follow-up

Exclusion criteria

Exclusion criteria: 1. Age less than 18 years or more than 80 years 2. MRI suggests Hepple Phase ? Osteochondral Lesions of the Talus associated with huge bone cyst 3. X-ray suggests malalignment of the lower limb or ankle joint (varus, valgus> 10 degrees) 4. Surgery history and shock wave treatment history of the ankle joint 5. Ankle OA, gout, local infection, coagulation abnormalities 6. Ankle ligamentous injury, or associated with other lesions that need surgical intervention 7. Pregnant women, deaf patients, or patients with mental disorders, etc., are excluded to ensure the accuracy of the follow-up 8. AOFAS scores of 10-12 weeks after ankle arthroscopy more than or equal to 75

Design outcomes

Primary

MeasureTime frame
1. Function of the ankle joint is measured using the AOFAS scoring system at baseline, 6 weeks, 3, 6 and 12 months 2. Pain in the ankle joint is measured using the visual analogue scale at baseline, 6 weeks, 3, 6 and 12 months 3. Repair of the OLT is assessed using MRI scanning pre-operatively, and 3 and 12 months post-operatively

Secondary

MeasureTime frame
1. Patient death rate is assessed by reviewing medical notes at 12 months 2. Serious complications that require other treatment are assessed by participant interviews at 12 months

Countries

China

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026