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Bimodal Ankle Stabilization System Improves Sleep Quality After Achilles Tendon Rupture Surgery: A Prospective Cohort Study of 120 Cases and Comparison of Three Fixation Methods

Bimodal Ankle Stabilization System Improves Sleep Quality After Achilles Tendon Rupture Surgery: A Prospective Cohort Study of 120 Cases and Comparison of Three Fixation Methods

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600124120
Enrollment
Unknown
Registered
2026-05-07
Start date
2022-01-21
Completion date
Unknown
Last updated
2026-05-11

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

Conditions

Achilles tendon rupture (acute complete Achilles tendon rupture)

Interventions

Dual-mode Ankle Stabilization System:None
Plaster Cast Group:None
Achilles Boot Group:None

Sponsors

Sihong Traditional Chinese Medicine Hospital of Hongyi Group
Lead Sponsor

Eligibility

Sex/Gender
All
Age
28 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18–65 years; 2. Diagnosed with acute complete Achilles tendon rupture (within =7 days post-injury) by ultrasound or MRI; 3. Underwent open or minimally invasive Achilles tendon repair surgery; 4. Received a single type of postoperative fixation (cast / Achilles boot / bimodal stable ankle system); 5. No cognitive impairment and able to independently complete questionnaire assessments; 6. Provide informed consent and willingness to comply with 6 weeks of follow-up.

Exclusion criteria

Exclusion criteria: 1. History of sleep disorders or current use of sedative-hypnotic agents; 2. Presence of concurrent fractures or severe injuries at other anatomical sites; 3. Comorbidities that impair wound healing, including diabetes mellitus and peripheral vascular disease; 4. Preoperative diagnosis of chronic pain syndrome; 5. History of mental illness; 6. Inability to complete the 6-week follow-up period.

Design outcomes

Primary

MeasureTime frame
Pittsburgh Sleep Quality Index (PSQI);

Secondary

MeasureTime frame
nighttime pain;anxiety (Self-Rating Anxiety Scale, SAS);functional recovery (AOFAS score);complications;patient satisfaction;economic cost;

Countries

China

Contacts

Public ContactGuo Xiaoming

Sihong Traditional Chinese Medicine Hospital of Hongyi Group

guixiaoming@163.com+86 159 9675 6522

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 16, 2026