Post-operative bracing following repair of the Achilles tendo

Not Applicable

• Conditions: Post-operative bracing following repair of the Achilles tendon; Surgery

• Registration Number: ISRCTN12135226
• Lead Sponsor: Shrewsbury and Telford Hospital NHS Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-11-03
• Last Update Posted: 15 November 2021
• Study Completion: 2028-05-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

1. Mid-substance Achilles tendon rupture, diagnosed clinically by the presence of a palpable gap to the Achilles tendon, and increased Achilles Tendon Resting Angle and a calf squeeze test
2. Aged 18-65 years
3. Presenting <15 days following rupture
4. Able to understand the spoken and written English language
5. After consultation wishes to have operative repair of the Achilles tendon rather than non-operative management
6. Available for 12 months follow up at Shrewsbury and Telford Hospital NHS Trust

Exclusion Criteria

1. Distal Achilles tendon rupture, identified by palpation of the distal stump ending <2 cm proximal to the Achilles insertion
2. Musculotendinous Achilles tendon ruptures, diagnosed by tenderness at the musculotendinous junction and on ultrasonography. Ultrasonography will be used for the confirmation of musculotendinous rupture rather than midsubstance rupture
3. Patients with diabetes mellitus, chronic inflammatory conditions, and musculoskeletal conditions preventing a single heel-rise prior to rupture
4. A previous ipsilateral or contralateral Achilles tendon rupture
5. Patients >110 kg and BMI >30 kg/m² owing to obesity giving an increased risk of wound, cast and functional brace complications

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Tendon elongation measured using the Heel-Rise Height Index (HRHI), comparing maximal the sustained heel-rise of the injured side to the non-injured side at 12 months following repair

Secondary Outcome Measures

Name	Time	Method
<br> Measured at 3, 6, 9 and 12 months following repair:<br> 1. Tendon length measured using the Achilles Tendon Resting Angle (ATRA)<br> 2. Symptoms and function measured using the Achilles tendon Total Rupture Score (ATRS)<br> 3. Work and sports activities assessed using the Tegner Score<br>