- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04050748
Achilles Tendon Lengthening With Traditional vs. Accelerated Rehab
Comparison of Tendon Lengthening With Traditional vs. Accelerated Rehab Following Achilles Tendon Repair: A Prospective Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
pture of the Achilles tendon is a relatively common injury among athletes involved in sports which require rapid direction changes and accelerations, such as soccer, sprinting, and basketball. Approximately 80% of ruptures occur during recreational sports, but it can also occur in sedentary individuals. An increase in recreational sport involvement has coincided with an increase in Achilles tendon ruptures. The most common age group for this injury is between 30 and 40 years old, and it is more likely to occur in males. It is thought that rupture in this age group is highest due to the co-occurrence of competitive sports and age- related degenerative changes.
Tendons changes occur as we age. There is decreased collagen density and fewer cross links, which alters the integrity of the tendon and its sheath. These changes, in addition to repetitive microtrauma, can cause the Achilles tendon to become calcified and thickened. Alteration in the elasticity of the tendon can set the stage for a rupture during abrupt increases in training intensity or during competitions.
The Achilles tendon is the largest tendon in the body, and it receives its blood supply from the gastroc- soleus complex. The blood supply is weakest between 2cm and 6cm from the tendon's insertion on the calcaneus, which is also the region where it is most likely to rupture.
The current recommendation for acute Achilles rupture is surgical repair, but there is no consensus regarding surgical versus nonsurgical treatment (immobilization, rehab, etc.). Surgical repair is thought to reduce the rates of re-rupture but also cause an increased risk of complications. There does not appear to be a difference in pre-injury activity levels between the two methods.
Tendons have excellent healing potential when the torn ends are reasonably approximated. Optimal tendon healing depends on surgical apposition and mechanical stabilization of the tendon ends. Once a tendon has been repaired, the suture material holds the tendon ends together, allowing fibroblasts to produce sufficient amounts of collagen to form a tendon callus.
In contrast with approximated tears, neglected ruptures with retraction of the proximal portion of the tendon heal with scar tissue, resulting in a lengthened, weakened musculotendinous unit. Poor muscle function will result without restoration of normal tendon length. Studies of tendon healing have indicated that early controlled motion and tensile stress applied to a repaired tendon promote earlier organization and remodeling of collagen fibers, decreased scar tissue, and increased strength compared with tendon immobilization.
Previous studies involving Rotator cuff repairs and ACL ligament reconstructions have employed the use of Tantalum Beads and roentgen stereophotogrammetric analysis to evaluate the creep or stretch of repaired soft tissue. These studies show that there appears to be soft tissue stretch/creep that occurs as tendon and ligament repairs/reconstructions heal. A surgeon's knowledge of how a repaired soft tissue will deform or stretch will be an undoubted asset to patient care and management. This knowledge will be invaluable for the surgeon in regards to appropriately preparing a tendon for repair, directly repairing the tendon and appropriately tensioning of the repair. It will also give valuable information for rehabilitation protocols and activity limitations post-operatively.
The safety of tantalum material has well been described in the orthopaedic literature. It is currently used in implants ranging from cervical spinal fusions to femoral rods without side effects.
Recently a prospective study looking at creep in rupture biceps tendons has been completed our institution. This study will use stereophotogrammetric analysis to expand our investigations to include Achilles tendon.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Michigan
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Detroit, Michigan, United States, 48202
- Health Ford Health System
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients with an acute tendon rupture less than 6 weeks were included in this study.
Exclusion Criteria:
- Underwent any additional concomitant procedures or tendon transfers, sustained prior ruptures, or had a chronic rupture.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Early Rehabiliation
6 weeks of non-weight bearing in addition to basic stretching exercises.
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Patients will be undergoing achilles tendon repair
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Active Comparator: Accelerated Rehabilitation
Patients will be non-weight bearing for 2 weeks.
After 2 weeks patients were transitioned to a boot with two heel wedges and were weight bearing as tolerated.
At 4 weeks, patients were transitioned to one wedge, and at 6 weeks patients were weight bearing as tolerated in a flat shoe.
Each heel wedge was ¾ inch tall.
After 6 weeks, patient's in both groups underwent identical rehab regimens per protocol
|
Patients will be undergoing achilles tendon repair
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Repair site lengthening
Time Frame: 2 years
|
Intratendinous and repair site lengthening were determined
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Achilles Tendon Total Rupture Score
Time Frame: 2 years
|
measure symptoms and physical activity levels after being treated for a complete Achilles tendon rupture
|
2 years
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 37283847
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Achilles Tendon Rupture
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Aristotle University Of ThessalonikiGeneral Hospital of Naoussa; Private Orthopedics Practice P. SymeonidisEnrolling by invitationAchilles Tendon Rupture | Achilles Tendon Injury | Achilles Tendon SurgeryGreece
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Henry Ford Health SystemRecruitingAchilles Tendon Rupture | Achilles Tendon SurgeryUnited States
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Aarhus University HospitalEnrolling by invitationAchilles Tendon Rupture | Achilles Tendon InjuryDenmark
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Chinese University of Hong KongNot yet recruitingAchilles Tendinopathy | Achilles Tendon RuptureHong Kong
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Penn State UniversityRecruiting
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Bispebjerg HospitalCompletedAchilles Tendon RuptureDenmark
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Region SkaneLund UniversityCompleted
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Hvidovre University HospitalCompletedAchilles Tendon RuptureDenmark
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Peking University Third HospitalCompletedAchilles Tendon RuptureChina
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University of OxfordNational Institute for Health Research, United KingdomCompletedAchilles Tendon RuptureUnited Kingdom
Clinical Trials on Achilles tendon repair
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Fowler Kennedy Sport Medicine ClinicThe Physicians' Services Incorporated FoundationCompleted
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Peking University Third HospitalCompletedAchilles Tendon RuptureChina
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Chinese University of Hong KongNot yet recruitingAchilles Tendinopathy | Achilles Tendon RuptureHong Kong
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Sahlgrenska University Hospital, SwedenGöteborg University; Vastra Gotaland Region; The Gothenburg Society of MedicineRecruitingMuscle Weakness | Muscle Atrophy | Arthroplasty Complications | Muscle TearSweden
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Southwest Hospital, ChinaUnknownAchilles Tendon ContractureChina
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Indus Hospital and Health NetworkCompletedAchilles Tendon Surgery | Club FootPakistan
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Eunice Kennedy Shriver National Institute of Child...CompletedDiabetes Mellitus | Foot Ulcer | Peripheral NeuropathyUnited States
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Krankenhaus Barmherzige Schwestern LinzActive, not recruitingAchilles Tendinopathy | Insertional Achilles TendinopathyAustria
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University of British ColumbiaCompletedPlantar Fasciitis | Plantar FasciopathyCanada
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Baxter Healthcare CorporationSynovis Surgical InnovationsWithdrawn