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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Amnion wrapping + Tenolysis | Experimental | Standard surgical tenolysis + wrapping of the released tendon with amnion. |
|
| Tenolysis control | Placebo Comparator | Standard surgical tenolysis alone |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Amnion Tendon Wrapping | Biological | Tendon is wrapped with the allograft |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Total Active Motion (TAM) | 6 months | |
| Passive Range of Motion (PROM) | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Patient-Rated Wrist Evaluation (PRWE) | Validated Outcome score/questionnaire specific to wrist function | 6 months |
| Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) | Validated Outcome score/questionnaire generalized to upper extremity conditions |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Michael P Gaspar, MD | Contact | michaelpgaspar@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Randall W Culp, MD | Thomas Jefferson University-Philadelphia Hand Center | Principal Investigator |
| Michael P Gaspar, MD | Thomas Jefferson University-Philadelphia Hand Center | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15882604 | Background | Vucekovich K, Gallardo G, Fiala K. Rehabilitation after flexor tendon repair, reconstruction, and tenolysis. Hand Clin. 2005 May;21(2):257-65. doi: 10.1016/j.hcl.2004.11.006. | |
| 25207280 | Background | Rouhani A, Tabrizi A, Ghavidel E. Effects of non-steroidal anti-inflammatory drugs on flexor tendon rehabilitation after repair. Arch Bone Jt Surg. 2013 Sep;1(1):28-30. Epub 2013 Sep 15. |
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| ID | Term |
|---|---|
| D052256 | Tendinopathy |
| D002921 | Cicatrix |
| D005355 | Fibrosis |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D013708 | Tendon Injuries |
| D014947 | Wounds and Injuries |
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| Surgical Tenolysis |
| Procedure |
Surgical release of peritendinous scarred tissue |
|
| 6 months |
| Complications | 2 weeks, One month, 3 months, 6 months |
| 23542850 | Background | Kohanzadeh S, Lugo L, Long JN. Safety of antiadhesion barriers in hand surgery. Ann Plast Surg. 2013 May;70(5):527-9. doi: 10.1097/SAP.0b013e31827eace2. |
| 24560801 | Background | Fairbairn NG, Randolph MA, Redmond RW. The clinical applications of human amnion in plastic surgery. J Plast Reconstr Aesthet Surg. 2014 May;67(5):662-75. doi: 10.1016/j.bjps.2014.01.031. Epub 2014 Jan 31. |
| 23660197 | Background | Wu YF, Tang JB. Apoptosis in adhesions and the adhesion-tendon gliding interface: relationship to adhesion-tendon gliding mechanics. J Hand Surg Am. 2013 Jun;38(6):1071-8. doi: 10.1016/j.jhsa.2013.03.012. Epub 2013 May 6. |
| 19687075 | Background | Ozboluk S, Ozkan Y, Ozturk A, Gul N, Ozdemir RM, Yanik K. The effects of human amniotic membrane and periosteal autograft on tendon healing: experimental study in rabbits. J Hand Surg Eur Vol. 2010 May;35(4):262-8. doi: 10.1177/1753193409337961. Epub 2009 Aug 17. |
| 22170243 | Background | Branford OA, Lee DA, Bader DL, Grobbelaar AO. The mechanics of flexor tendon adhesions. J Hand Surg Eur Vol. 2012 Jul;37(6):555-63. doi: 10.1177/1753193411432675. Epub 2011 Dec 14. |
| 27751716 | Background | Gaspar MP, Abdelfattah HM, Welch IW, Vosbikian MM, Kane PM, Rekant MS. Recurrent cubital tunnel syndrome treated with revision neurolysis and amniotic membrane nerve wrapping. J Shoulder Elbow Surg. 2016 Dec;25(12):2057-2065. doi: 10.1016/j.jse.2016.09.013. Epub 2016 Oct 14. |
| D010335 |
| Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |