Adhesions Nos Postoperative, Fibrosis, Scar, Tendinopathy
Conditions
Brief summary
Tendon adhesions of the hand remain a ubiquitous problem facing hand surgeons and hand therapists alike. Despite their commonality, no consensus exists as to the best means of preventing adhesions, or the most ideal methods to treat them once they have occurred. The purpose of this study is to compare patient outcomes after standard operative tenolysis performed for adhesions of the hand to outcomes after tenolysis with the use of allograft human amniotic membrane.
Detailed description
Patients who are scheduled to undergo operative tenolysis of the flexor and/or extensor tendons of the hand will be recruited. Our target enrollment is 40 patients (20 control plus 20 experimental), based on the power analysis detailed in the next paragraph. Enrolled patients will be randomized to either standard operative tenolysis, or tenolysis with placement of AlloWrap. Randomization will be performed by computerized random number generator. All surgeries will be performed by one senior fellowship-trained hand surgeon. Baseline measurements of total active motion (TAM), passive range of motion (PROM), and survey scores of the Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) and Patient Rated Wrist Evaluation (PRWE) will be recorded pre-operatively. In addition, patients' pain level will be assessed using the visual analog scale (VAS) both at rest, and during the examination. These same values will be re-evaluated at post-operative follow-up visits at 2 weeks, 1 month, 3 months and 6 months. PROM will also be evaluated intra-operatively by the surgeon, and documented.
Interventions
BIOLOGICALAmnion Tendon Wrapping
Tendon is wrapped with the allograft
PROCEDURESurgical Tenolysis
Surgical release of peritendinous scarred tissue
Sponsors
Thomas Jefferson University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* All adult patients deemed candidates for operative tenolysis of the hand or wrist * Age ≥18
Exclusion criteria
* Patients younger than 18 years at the time of surgery; * Any patient who would not be able or willing to comply with the protocol or perform assessments; * Patients with medical conditions that may preclude placement of human biological membrane; * Patients who have previously undergone tenolysis on the operative hand; * Patients that will have multiple surgeries that are deemed as possible confounders, particularly those requiring an additional incision; * Is physically or mentally compromised (i.e. being currently treated for a psychiatric disorder, senile dementia, Alzheimer's disease) in a manner that would compromise his or her ability to participate in the clinical study; * Is a prisoner; * Is a transient.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total Active Motion (TAM) | 6 months |
| Passive Range of Motion (PROM) | 6 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient-Rated Wrist Evaluation (PRWE) | 6 months | Validated Outcome score/questionnaire specific to wrist function |
| Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) | 6 months | Validated Outcome score/questionnaire generalized to upper extremity conditions |
| Complications | 2 weeks, One month, 3 months, 6 months | — |
Contacts
Primary ContactMichael P Gaspar, MD
Outcome results
None listed