Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of the study is to investigate if delayed loading following surgical treated Achilles tendon rupture influence the clinical outcome and muscle and tendon structure after one year.
The investigators hypothesize that delaying the gradual introduction of loading in the initial 26 weeks may reduce the heel-rise deficit (primary outcome) and thus improve the clinical outcome one year after surgery (primary endpoint).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Early mobilization (loading) | Active Comparator | This constitutes the currently accepted regime and is therefore considered the control group. Cast/orthopedic boot for 6 weeks No weight bearing: week 0-2 Partiel weightbearing from week 3 Full weightbearing from week 7 ROM exercises 5 times a day from week 3 |
|
| Delayed mobilization (loading) | Experimental | Loading of the Achilles tendon is delayed for 6 weeks. Cast/orthopedic boot for 12 weeks No weight bearing: week 0-6 Partiel weightbearing from week 7 Full weightbearing from week 13 ROM exercises 5 times a day from week 3 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rehabilitation (physiotheraphy) | Other | Time of loading, range of motion exercises, strength training |
|
| Measure | Description | Time Frame |
|---|---|---|
| Heel-rise test | Heel-rise height deficit on the injured side relative to the uninjured side | One-year follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Tendon length and cross-sectional area | MRI will be used to measure free tendon length, tendon cross-sectional area and tendon length up to the gastrocnemius insertion. | 1 week, 3 months, 6 months and 1 year |
| The Achilles tendon rupture score (ATRS) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Peter Magnusson, Professor | Institute of Sportsmedicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bispebjerg Hospital | Copenhagen | 2400 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41059465 | Derived | Hoeffner R, Svensson RB, Gillani SZ, Linden FH, Magnusson SP. Morphological Changes One Year After Achilles Tendon Rupture Repair: A Comparison of Loading Strategies. Transl Sports Med. 2025 Sep 28;2025:1778630. doi: 10.1155/tsm2/1778630. eCollection 2025. | |
| 38353060 | Derived | Hoeffner R, Agergaard AS, Svensson RB, Cullum C, Mikkelsen RK, Konradsen L, Krogsgaard M, Boesen M, Kjaer M, Magnusson SP. Tendon Elongation and Function After Delayed or Standard Loading of Surgically Repaired Achilles Tendon Ruptures: A Randomized Controlled Trial. Am J Sports Med. 2024 Mar;52(4):1022-1031. doi: 10.1177/03635465241227178. Epub 2024 Feb 14. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 1, 2022 | Aug 23, 2022 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D012046 | Rehabilitation |
| ID | Term |
|---|---|
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
| D013812 | Therapeutics |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The Achilles tendon rupture score questionnaire is a patient-reported outcome with a possible score from 1-100, where higher scores mean a better outcome.
| Recall before injury and 1 year |
| Muscle fascicle length and doppler activity in the tendon | Muscle fascicle length and doppler activity in the tendon will be measured with ultrasonography | 2 weeks, 3 months, 6 months and 1 year |
| Isokinetic plantar flexion muscle strength | The Biodex is used to obtain isokinetic plantar flexion muscle strength during maximal contractions. | 1 year |
| Physical activity level | A questionnaire is used to measure the physical activity level (including type of activity) of the participants. | Recall before injury and 1 year |
| Heel-rise work | An instrumented heel-rise test will be conducted to measure work capacity | 6 months and 1 year |
| The Achilles tendon resting angle (ATRA) | Achilles tendon resting angle will be measured using a standard goniometer. Measurements will be obtained with the knee flexed and extended. | 2 weeks, 3 months, 6 months and 1 year |
| D006296 |
| Health Services |
| D005159 | Health Care Facilities Workforce and Services |