Achilles Tendon Rupture Patient Outcomes at 12 Months
ConditionAchilles Tendon Rupture
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorLiverpool University Hospitals NHS Foundation Trust
About this trial
Achilles tendon rupture is a common injury that can significantly impact strength, function, and quality of life. While non-surgical management using structured rehabilitation protocols such as the Swansea Morriston Achilles Rupture Treatment (SMART) protocol is increasingly adopted, there is limited evidence on long-term recovery outcomes, particularly beyond six months.
This study aims to evaluate recovery at 12-15 months following non-surgical management of Achilles tendon rupture in an NHS population. Participants will attend a single study visit during which plantarflexor muscle strength will be assessed using isokinetic dynamometry, and patient-reported outcomes will be collected using the Achilles Tendon Total Rupture Score (ATRS) and EQ-5D-5L questionnaire. Achilles Tendon Resting Angle (ATRA) will also be measured to provide an estimate of tendon elongation.
The primary objectives are to quantify plantarflexor strength recovery and self-reported functional outcomes. Secondary analyses will explore associations between strength, tendon elongation, quality of life, return to sport, and pre-injury symptoms.
This cross-sectional observational study will recruit adult patients managed non-surgically with the SMART protocol from Liverpool University Hospitals NHS Foundation Trust. Findings will provide clinically relevant data on long-term recovery following conservative treatment and may inform rehabilitation strategies and return-to-activity decision-making.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Have a confirmed diagnosis of Achilles tendon rupture, diagnosed clinically and recorded within the NHS clinical database
Have been managed non-surgically using the SMART (Swansea Morriston Achilles Rupture Treatment) rehabilitation protocol
Be between 12 and 15 months post-injury at the time of study assessment
Be able and willing to provide written informed consent to participate in the study
Disqualifiers
Unable to provide informed consent
Have previously undergone surgical repair of the Achilles tendon or experienced a re-rupture
Have a neuromuscular or neurological condition that could affect lower limb strength or function
Did not follow the SMART rehabilitation protocol for non-surgical management
Trial population
Adults who previously sustained an Achilles tendon rupture and were treated non-surgically using the SMART rehabilitation protocol within Liverpool University Hospitals NHS Foundation Trust. Eligible participants are identified from an existing clinical database and represent patients 12-15 months post-injury who completed standard physiotherapy rehabilitation. All participants are drawn from routine NHS orthopaedic and physiotherapy services at Aintree and Broadgreen Hospitals.
Trial design
Design model
Cohort
Time perspective
Cross-sectional
Treatments tested in this trial
Non-Surgical Management Using the SMART Protocol
Other interventionParticipants previously received standard non-surgical treatment for Achilles tendon rupture following the SMART (Swansea Morriston Achilles Rupture Treatment) functional rehabilitation protocol as part of routine NHS care. No interventions are assigned as part of this study; all data are collected at a single follow-up visit.
Treatment groups
115 Participants
are divided into 1 treatment groupGroup A: Non-Surgically Managed Achilles Tendon Rupture Cohort1 intervention
Trial outcomes
Primary outcomes
1
Isokinetic plantarflexor strength - Peak Torque
Peak plantarflexion torque will be measured using isokinetic dynamometry. Peak torque (Newton metres \[Nm\]) represents the maximum force generated by the plantarflexor muscles during a maximal voluntary contraction. Unit of Measure: Newton metres (Nm) Minimum value: 0 Nm Maximum value: No fixed maximum value Higher values indicate: Greater plantarflexor muscle strength (better outcome)
Time frame
12-15 months post-injury (single study visit)2
Isokinetic Plantarflexion Strength Normalised to Body Weight
Peak plantarflexion torque normalised to body weight, measured using isokinetic dynamometry. Results are expressed as Newton metres per kilogram (Nm/kg) to facilitate comparison of plantarflexor muscle strength between individuals of different body sizes. Unit of Measure: Newton metres per kilogram (Nm/kg) Minimum Value: 0 Nm/kg Maximum Value: No fixed maximum value Higher values indicate: Greater plantarflexor muscle strength relative to body weight (better outcome)
Time frame
12-15 months post injury3
Isokinetic Plantarflexion Strength Limb Symmetry Index (LSI)
Limb Symmetry Index (LSI) for isokinetic plantarflexion strength. LSI is calculated as the peak torque of the injured limb divided by the peak torque of the uninjured limb and expressed as a percentage. An LSI of 100% indicates equal strength between limbs, while values below 100% indicate a strength deficit in the injured limb. Unit of Measure: Percent (%) Minimum Value: 0% Maximum Value: No fixed maximum value Higher values indicate: Greater symmetry between injured and uninjured limbs and therefore a better outcome.
Time frame
12-15 months post injury4
Achilles Tendon Total Rupture Score
The Achilles Tendon Total Rupture Score (ATRS) is a validated patient-reported outcome measure assessing symptoms, physical activity, and functional limitations following Achilles tendon rupture. Scores range from 0 to 100, with higher scores indicating better perceived recovery and fewer symptoms. Time Frame: 12-15 months post-injury (single study visit) Unit of Measure: Points Minimum Value: 0 Maximum Value: 100 Higher scores indicate: Better outcome (fewer symptoms and greater function) Lower scores indicate: Worse outcome (more symptoms and greater functional limitation)
Time frame
12-15 months post-injury (single study visit)Secondary outcomes
1
Correlation Between Achilles Tendon Total Rupture Score and Peak Plantarflexion Torque
Correlation between subjective recovery measured by the Achilles Tendon Total Rupture Score (ATRS) and objective plantarflexor muscle strength measured as peak plantarflexion torque during isokinetic dynamometry. Unit of Measure: Correlation coefficient (r) Minimum Value: -1 Maximum Value: 1 Interpretation: Values closer to ±1 indicate a stronger relationship between ATRS and peak plantarflexion torque. Values closer to 0 indicate a weaker relationship.
Time frame
12-15 months post injury2
Correlation Between Achilles Tendon Total Rupture Score and Plantarflexion Strength Limb Symmetry Index
Correlation between subjective recovery measured by the Achilles Tendon Total Rupture Score (ATRS) and objective plantarflexion strength symmetry measured using the Limb Symmetry Index (LSI). Time Frame: 12-15 months post-injury (single study visit) Unit of Measure: Correlation coefficient (r) Minimum Value: -1 Maximum Value: 1 Interpretation: Values closer to ±1 indicate a stronger relationship between ATRS and Limb Symmetry Index. Values closer to 0 indicate a weaker relationship.
Time frame
12-15 months post injury3
Health-related quality of life - EuroQol Five-Dimension Five-Level Questionnaire (EQ-5D-5L) Summed Dimension Score
Health-related quality of life will be assessed using the EuroQol 5-Dimension, 5-Level (EQ-5D-5L) Questionnaire. The EuroQol Five-Dimension Five-Level Questionnaire (EQ-5D-5L) is a patient-reported measure of health-related quality of life consisting of five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is rated on a five-level scale from no problems to extreme problems. Minimum value: 5 Maximum value: 25 Direction of scale: Lower scores indicate a better outcome (fewer health problems); higher scores indicate a worse outcome (more severe health problems).
Time frame
12-15 months post injury4
Health related quality of life - EuroQol Visual Analogue Scale
The EuroQol Visual Analogue Scale (EQ VAS) is a self-reported measure of overall health status. Participants rate their current health on a vertical visual analogue scale ranging from 0 ("the worst health you can imagine") to 100 ("the best health you can imagine"). Minimum value: 0 Maximum value: 100 Higher scores indicate: Better self-rated health status Lower scores indicate: Worse self-rated health status
Time frame
12-15 months post injurySponsors and contacts
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Source ClinicalTrials.gov