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Completed

NCT Number: NCT00489749

A Study Comparing Protected Early Weightbearing Versus Non-Weightbearing After Surgery for Achilles Tendon Rupture

The purpose of this study was to determine the effect of protected early weightbearing (PEWB) compared to non-weightbearing (NWB) after surgery for an Achilles tendon rupture (ATR) on health related quality of life (HRQL) in the initial six week period after surgery, functional recovery over time, return to work and activity and complications. We hypothesized that PEWB following ATR repair would result in: i) improved HRQL in the initial postoperative period, ii), a quicker recovery of HRQL, strength and endurance, iii) earlier return to work and sport, and iv) no increase in complications, such as re-rupture compared to NWB.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alberta Hospital

Edmonton, Alberta, T6G 2B7, Canada

About this study

Achilles tendon rupture (ATR) is commonly treated with open surgical repair. Following surgical repair, there are a variety of protocols, ranging from complete immobilization to immediate postoperative mobilization with early weightbearing. However, no clear consensus regarding the optimal postoperative rehabilitation protocol for ATRs exists. Early rehabilitation after ATR has been shown to be beneficial in animal and human studies. Human prospective studies and randomized controlled trials have shown that early postoperative mobilization do not pose additional risks compared to cast immobilization, with a trend toward a reduction in lost work days and an earlier return to sport. However, these trials define early postoperative mobilization differently (i.e. use different combinations of weightbearing and range of motion). This makes it difficult to determine which factor in the early rehabilitation process plays an important role in optimizing recovery. An important component of early rehabilitation is weightbearing.

Comparison: Patients weightbearing in the early rehabilitation period after surgical repair of the Achilles tendon compared to patients non-weightbearing after the surgical repair of the Achilles tendon repair. With the exception of weightbearing status, both groups performed the same rehabilitation program.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • closed and complete Achilles tendon rupture
  • seen within 14 days of injury in hospital

Exclusion criteria

  • unwilling to follow the study's rehabilitation protocol
  • unable to speak or read English
  • co-morbid conditions such as diabetes and neurological or collagen disease
  • pregnancy
  • recent immunosuppressant or fluoroquinolone therapy
  • previous Achilles tendon symptoms
  • previous ipsilateral rupture
  • sustained an additional injury not allowing weightbearing
  • an Achilles tendon avulsion injury
  • unfit for surgery

Treatment and study plan

Protected early weightbearing/Achilles tendon surgery

Procedure

Primary outcomes

  1. Health related quality of life: Short form 36 questionnaire

    Time frame: six weeks

Secondary outcomes

  1. Health related quality of life: Short Form-36 questionnaire

    Time frame: 3 and 6 months

  2. Level of activity: tailored question

    Time frame: six weeks, 3 months, and 6 months

  3. Major complications: chart review

    Time frame: 6 weeks, 3 months, and 6 months

  4. Minor complications: chart review

    Time frame: 6 weeks, 3 months, and 6 months

  5. Isometric muscle strength: hand held myometer

    Time frame: 6 weeks, 3 months, and 6 months

  6. Muscle endurance: heel raise counting device

    Time frame: 6 months

  7. Calf circumference: standardized tape measurement

    Time frame: 6 weeks, 3 months, and 6 months

  8. Return to work/sport: tailored question

    Time frame: 6 weeks, 3 months, and 6 months

  9. Physiotherapy utilization: tailored question

    Time frame: 6 weeks, 3 months, and 6 months

Sponsors and collaborators

Lead sponsor

University of Alberta

Other

Collaborators

  • DonJoy Orthotics
  • Edmonton Orthopaedic Research Society
  • Royal Alexandra Hospital

Registry information

Official study title

The Influence of Protected Early Weightbearing Versus Nonweightbearing After Surgical Repair of the Achilles Tendon

Important dates

Study start
2003
Study completion
2006
First posted
Jun 21, 2007
Registry last updated
Jun 21, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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